Comprehensive it pump

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    How prevalent are side effects in patients receiving intrathecal morphine and are patients satisfied with the therapy?
    To answer these questions, a group at Rush-Presbyterian-St. Luke’s Hospital in Chicago conducted a retrospective survey of 35 implanting physicians and published their report in 1996. They collected 429 usable case reports, of which 2/3 of the reported patients had nonmalignant pain, and 1/3 had cancer pain. 1
    Some patients experienced adverse events from intrathecal morphine. However, the majority of the patients in this study reported increases in their ability to perform activities of daily living:
    22.8% of patients had great increases in activities of daily living,
    34.3% had moderate increases, and
    24.6% had slight increases in ADLs.
    Of 77 patients contacted as part of a telephone survey, many reported high rates of satisfaction with the therapy.
    66.7% of patients were very satisfied,
    20.2% of patients were moderately satisfied, and
    1.2% of patients were slightly satisfied with the therapy.
    1 Paice JA, Penn RD, Shott S. Intraspinal Morphine for Chronic Pain: A Retrospective, Multicenter Study, JPSM, Feb. 1996; 11(2):71-80.
  • Many studies show positive results of intrathecal drug delivery in controlling pain, with 64% to 95% of treated patients receiving good to excellent pain relief. For cancer pain, the majority of patients attained good to excellent pain relief.
    Patients reported significant improvement in functional status and, therefore, the ability to interact with family and friends. Patients were also able to reduce systemic medication.
    These studies were at single-centers, with small numbers of patient and varying patient- selection criteria. Measures of success varied widely and, in some cases, were poorly defined.
    ReferenceNo. Pts Cancer Non-cancer Good-Excellent Pain Relief
    Paice et al 1996429 1/3 2/395%
    Devulder 1994 33All - 76%
    Follett et al 1992 37 35 2 77%
    Onofrio, Yakash 1990 53 All - 64%
    Penn, Paice 1987 43 35 8 84%
    Shetter, 1986 14 All - 79%
    Krames, Gershow 1985 17 All -88%
    There was a need for a multicenter, randomized, prospective trial comparing intrathecal drug delivery with standard comprehensive medical management.
  • In the IDDS group, the estimated cumulative survival was 53.9% at 6 months compared with 37.2% for the CMM group (p=0.06, log-rank test).
    Because survival was not a planned study endpoint, but a coincidental finding, this result must be interpreted with appropriate caution.
    Reduction in composite drug toxicity was associated with improved survival(estimated hazard ration, 0.95 per 1-point drop in composite toxicity score; p=0.05). Because the IDDS group experienced a larger average reduction in toxicity score, the data suggests that improved mortality in the IDDS group may be partially explained by effects of the intrathecal pain therapy.
    Journal of Clinical Oncology, Vol 20, No 19, October 1, 2002: 4040-4049.
  • Comprehensive it pump

    1. 1. Intrathecal Infusion Patient SelectionIntrathecal Infusion Patient Selection Pre-Pump-Implant Trials Surgical Implantation TechniquesSurgical Implantation Techniques Intraoperative Complications Post-Operative ComplicationsPost-Operative Complications Outcome Studies AlgosresearchAlgosresearch Algosresearch.orgAlgosresearch.org
    2. 2. SLIDE INDEXSLIDE INDEX Contributions by J Patrick Couch, Elliott Krames, K Follett, J OrdiaContributions by J Patrick Couch, Elliott Krames, K Follett, J Ordia  Physician Qualifications/Clinics- Slide 4Physician Qualifications/Clinics- Slide 4  Patient Selection- Slide 7Patient Selection- Slide 7  Neuraxial Screening Trials- Slide 34Neuraxial Screening Trials- Slide 34  Surgical Techniques- Slide 87Surgical Techniques- Slide 87  Intraoperative Complications- Slide 148Intraoperative Complications- Slide 148  Early Postoperative Complications-Slide 161Early Postoperative Complications-Slide 161  Late Postoperative Complications-Slide 189Late Postoperative Complications-Slide 189  Medication Effects-Slide 226Medication Effects-Slide 226  Selected Outcome Studies- Slide 252Selected Outcome Studies- Slide 252
    3. 3. WE EACH HAVE OUR OWN TALENTS Not everyone should be implanting pumps
    4. 4. PhysicianPhysician Qualifications/TrainingQualifications/Training  Because pain medicine has no residencyBecause pain medicine has no residency program, no defined scope of practice, or noprogram, no defined scope of practice, or no defined standards for intrathecal pumpdefined standards for intrathecal pump implantation, the qualifications are nebulousimplantation, the qualifications are nebulous  From a practical standpoint, only full time painFrom a practical standpoint, only full time pain physicians or those with full time pain coveragephysicians or those with full time pain coverage by other physicians qualified to implant pumpsby other physicians qualified to implant pumps should be implanting these devicesshould be implanting these devices  Surgical skills are very useful and may helpSurgical skills are very useful and may help avoid or reduce complicationsavoid or reduce complications  Some pain physicians will perform only the trialSome pain physicians will perform only the trial then perform the refills for an implantingthen perform the refills for an implanting neurosurgeon.neurosurgeon.
    5. 5. Clinic SetupClinic Setup  An intrathecal pump service is far more complexAn intrathecal pump service is far more complex than a simple block or RF servicethan a simple block or RF service  Requirements include: FDA tracking, medicationRequirements include: FDA tracking, medication log, access to medical records 24 hours a day inlog, access to medical records 24 hours a day in case the patient is admitted to another institution,case the patient is admitted to another institution, nurse in charge of tracking/refills/medicationnurse in charge of tracking/refills/medication orders, 24 hour a day availability by a physicianorders, 24 hour a day availability by a physician qualified to implant pumps and managequalified to implant pumps and manage complications, quality assurance in intrathecalcomplications, quality assurance in intrathecal medication sterility and expiration times, pumpmedication sterility and expiration times, pump refill kits, screening psych tools pre-implantation,refill kits, screening psych tools pre-implantation, billing is understood, contacting patients re: refillsbilling is understood, contacting patients re: refills
    6. 6. Pre-Implantation:Pre-Implantation:  Conservative Measures ExhaustedConservative Measures Exhausted  High Dose Oral or Transdermal Opiates HaveHigh Dose Oral or Transdermal Opiates Have Been Tried with Intractable Side EffectsBeen Tried with Intractable Side Effects  Psych Screen OKPsych Screen OK  Extended Informed ConsentExtended Informed Consent  Insurance approval or criteria metInsurance approval or criteria met  Appropriate venue: Medicare cannot beAppropriate venue: Medicare cannot be implanted in an ASCimplanted in an ASC  Functional Intrathecal TrialFunctional Intrathecal Trial  Systems are in place for office refills, pumpSystems are in place for office refills, pump tracking, physician backup for vacationstracking, physician backup for vacations  Malpractice InsuranceMalpractice Insurance
    7. 7. Intrathecal InfusionIntrathecal Infusion TherapyTherapy:: Patient SelectionPatient Selection
    8. 8. Many Choices in PainMany Choices in Pain ManagementManagement
    9. 9. Patient Selection:Patient Selection: The Good, The Bad,The Good, The Bad, and the Uglyand the Ugly
    10. 10. Classic Patient Selection CriteriaClassic Patient Selection Criteria  Seven patient selection criteria for intrathecalSeven patient selection criteria for intrathecal pump implantation, Elliot Krames, M.D.pump implantation, Elliot Krames, M.D. J PainJ Pain & Symptom Mgt., 1996& Symptom Mgt., 1996:: • More conservative therapies have failedMore conservative therapies have failed • An observable pathology exists that is concordantAn observable pathology exists that is concordant with the pain complaintwith the pain complaint • Further surgical intervention is not indicatedFurther surgical intervention is not indicated • No serious untreated drug habituation existsNo serious untreated drug habituation exists • Psychological evaluation and clearance forPsychological evaluation and clearance for implantation has been obtainedimplantation has been obtained • No contraindications to implantation existNo contraindications to implantation exist • AA Screening TestScreening Test has been successfulhas been successful
    11. 11. Considerations for ImplantationConsiderations for Implantation Whitworth, 2003Whitworth, 2003  Medically necessaryMedically necessary  Failure of conservative therapyFailure of conservative therapy  Psychologically stablePsychologically stable  Financially feasibleFinancially feasible  Refill considerations (timing, cost)Refill considerations (timing, cost)  Adequate trialAdequate trial  No anticipated definitive surgeryNo anticipated definitive surgery  Risk/benefit ratio acceptableRisk/benefit ratio acceptable  Technical pump implant considerationsTechnical pump implant considerations
    12. 12. Common Indications forCommon Indications for Intrathecal TherapyIntrathecal Therapy  Chronic non-malignant pain treatmentChronic non-malignant pain treatment  Cancer pain treatmentCancer pain treatment  Spasticity treatmentSpasticity treatment  Chemotherapy administrationChemotherapy administration
    13. 13. Medical Conditions That MayMedical Conditions That May Respond to IntrathecalRespond to Intrathecal TherapyTherapy  CRPS with spasticity or more than 1CRPS with spasticity or more than 1 extremity involvementextremity involvement  Peridural fibrosisPeridural fibrosis  Neuropathic pain (less responsive)Neuropathic pain (less responsive)  Spasticity (s/p CVA, MS, dystonias, CP)Spasticity (s/p CVA, MS, dystonias, CP)  CNS spinal cord tumorsCNS spinal cord tumors  Central pain (poor response)Central pain (poor response)  FMS (variable response-need good trial)FMS (variable response-need good trial)
    14. 14. Medical NecessityMedical Necessity Means:Means: Other more conservative therapies haveOther more conservative therapies have been tried (often for more than 2-3 mos)been tried (often for more than 2-3 mos)  Opiate/local/alpha2 responsive pain orOpiate/local/alpha2 responsive pain or baclofen responsiveness of spasticitybaclofen responsiveness of spasticity  There are no definitive surgical treatmentsThere are no definitive surgical treatments availableavailable  The therapy is a standard accepted andThe therapy is a standard accepted and indicated therapy for the particularindicated therapy for the particular conditioncondition
    15. 15. Conservative Therapy FailureConservative Therapy Failure  Oral or transdermal medications (severalOral or transdermal medications (several types) produce significant side effects oftypes) produce significant side effects of mentation changes, hypersedation, ormentation changes, hypersedation, or inadequate pain relief. Constipation,inadequate pain relief. Constipation, pruritis, urinary retention are commonpruritis, urinary retention are common features of intrathecal therapy therefore thefeatures of intrathecal therapy therefore the presence of these side effects during oralpresence of these side effects during oral or transdermal opiate therapy is not aor transdermal opiate therapy is not a definitive indication for intrathecal therapy.definitive indication for intrathecal therapy. Nausea and vomiting may be improvedNausea and vomiting may be improved with IT therapy.with IT therapy.
    16. 16. Other Failure Indicators inOther Failure Indicators in Conservative TherapyConservative Therapy  Failure to significantly affect pain whenFailure to significantly affect pain when targetedtargeted  Failure to significantly improveFailure to significantly improve functionalityfunctionality  Significant side effects are occurring withSignificant side effects are occurring with conservative therapy which are intolerableconservative therapy which are intolerable in spite of adjunctive measuresin spite of adjunctive measures
    17. 17. Some Contraindications BasedSome Contraindications Based on Conservative Therapyon Conservative Therapy ObservationsObservations  Patient passivityPatient passivity  Unwilling to participate in functionalUnwilling to participate in functional restoration programs, injectionrestoration programs, injection therapies, or psychological treatmenttherapies, or psychological treatment  Excessive optimism regarding postExcessive optimism regarding post implant pain reliefimplant pain relief  You have become the messiahYou have become the messiah
    18. 18. Other ContraindicationsOther Contraindications  Pre-existing pedal edema: edema canPre-existing pedal edema: edema can become severe in 30% with intrathecal MSbecome severe in 30% with intrathecal MS infusions (Eur J Pain. 2000;4(4):361-5.infusions (Eur J Pain. 2000;4(4):361-5. Leg edema from intrathecal opiateLeg edema from intrathecal opiate infusions. Aldrete JA)infusions. Aldrete JA)  Significant systemic side effects ofSignificant systemic side effects of transdermal, oral, or parenteral drugs oftransdermal, oral, or parenteral drugs of the same type to be infusedthe same type to be infused  Any underlying infection at the time ofAny underlying infection at the time of surgerysurgery
    19. 19. PsychPsych EvalEval
    20. 20. Psychological ConsiderationsPsychological Considerations  Psychological assessment: (1) exposesPsychological assessment: (1) exposes psychological factors that should bepsychological factors that should be addressed in treatment; (2) suggestsaddressed in treatment; (2) suggests specific treatments that may help resolvespecific treatments that may help resolve psychological risk factors; (3) facilitatespsychological risk factors; (3) facilitates patient selection for specific painpatient selection for specific pain therapies; and (4) provides clues totherapies; and (4) provides clues to evaluate the patient's response to aevaluate the patient's response to a screening test or treatment.screening test or treatment.
    21. 21. Important Psych ContraindicationsImportant Psych Contraindications  Untreated moderate to severe depressionUntreated moderate to severe depression  Severe personality disordersSevere personality disorders  SuicidalSuicidal  HomicidalHomicidal  Severe obsessive-compulsiveSevere obsessive-compulsive  SomatizationSomatization  Substance abuseSubstance abuse  Unable to tolerate implantation of subcutaneousUnable to tolerate implantation of subcutaneous pump due to self image problems or underlyingpump due to self image problems or underlying psych problemspsych problems  Manipulative or chronically dissatisfiedManipulative or chronically dissatisfied
    22. 22. Psychomimetric InstrumentsPsychomimetric Instruments  MMPIMMPI  BHIBHI  P90P90  P3P3  Face to face evaluation with psychologistFace to face evaluation with psychologist (most important of all)(most important of all)
    23. 23. Substance Abuse IssuesSubstance Abuse Issues  Cannot be definedCannot be defined without a narcoticwithout a narcotic agreement whichagreement which spells out clinicspells out clinic rules forrules for prescribing andprescribing and violations of theseviolations of these rules.rules.  Patient induced overdose,Patient induced overdose, script alteration, threats ofscript alteration, threats of legal action unless narcoticslegal action unless narcotics are prescribed, andare prescribed, and diversion of meds arediversion of meds are absolute issues.absolute issues.  Lost or stolen drugs,Lost or stolen drugs, positive UDS for illegalpositive UDS for illegal drugs, negative UDS fordrugs, negative UDS for prescribed drugs, repeatedprescribed drugs, repeated calls afterhours for drugs,calls afterhours for drugs, failure to keep scheduledfailure to keep scheduled appts, etc. all warrantappts, etc. all warrant
    24. 24. By implantingBy implanting an intrathecalan intrathecal pump, you arepump, you are married to themarried to the patientpatient
    25. 25. Marriage and IT PumpsMarriage and IT Pumps  Dance a little before you decide to getDance a little before you decide to get marriedmarried  Don’t marry anyone you don’t like (divorceDon’t marry anyone you don’t like (divorce of a patient with a pump is messy)of a patient with a pump is messy)  Don’t implant a pump to silence a patientDon’t implant a pump to silence a patient from complaining about pain: it will not.from complaining about pain: it will not. Patients will still complain just as muchPatients will still complain just as much after implantation.after implantation.
    26. 26. Financial ConsiderationsFinancial Considerations  Acquisition cost toAcquisition cost to hospitals/ASC forhospitals/ASC for pump plus catheterpump plus catheter ranges from $5,500 toranges from $5,500 to 10,500.10,500.  Implant costs plusImplant costs plus trial plus acquisitiontrial plus acquisition costs may exceedcosts may exceed $20,000$20,000  Break even pointBreak even point usually does not occurusually does not occur until 9-15 months afteruntil 9-15 months after implantation (moneyimplantation (money savings on oral meds)savings on oral meds)  Medicaid does notMedicaid does not cover pumps.cover pumps.  Because of the costs,Because of the costs, the deductable alonethe deductable alone can thwartcan thwart implantationimplantation
    27. 27. Do Not ImplantDo Not Implant ProgrammableProgrammable Pumps In Patients Who:Pumps In Patients Who:  May not have insurance in the futureMay not have insurance in the future  Who are anticipated to have Medicaid asWho are anticipated to have Medicaid as their insurertheir insurer  Who do not have a demonstrated need forWho do not have a demonstrated need for programmed dosingprogrammed dosing  Who do not follow a rigid schedule everyWho do not follow a rigid schedule every dayday  Have HMO Medicare: Costs May Not BeHave HMO Medicare: Costs May Not Be Covered-check with the intermediaryCovered-check with the intermediary
    28. 28. Pump Refill ConsiderationsPump Refill Considerations  Meds to refill the pump may haveMeds to refill the pump may have acquisition costs of $20-$500 per refillacquisition costs of $20-$500 per refill or much higher for Prialtor much higher for Prialt  Pump refill kits range from $15-$35 perPump refill kits range from $15-$35 per refillrefill  Shorter refill times in cancer patientsShorter refill times in cancer patients  Longer refill times in those with chronicLonger refill times in those with chronic pain on stable therapypain on stable therapy  Pump delivery is 10% plus or minusPump delivery is 10% plus or minus  Transportation vs. Home RefillTransportation vs. Home Refill
    29. 29. Importance of TrialImportance of Trial  Next to psych eval, trial is most importantNext to psych eval, trial is most important feature leading to intrathecal implantationfeature leading to intrathecal implantation  Adequate pain reductionAdequate pain reduction  Increase functionalityIncrease functionality  Lack of significant side effectsLack of significant side effects
    30. 30. Acceptable Risk RatioAcceptable Risk Ratio  Severe Pulmonary disease patientsSevere Pulmonary disease patients may pose intraoperative risks but lessmay pose intraoperative risks but less long term risk vs. Oral narcoticslong term risk vs. Oral narcotics  Uncontrolled diabetes patients will notUncontrolled diabetes patients will not heal from implantation.heal from implantation.  Adequate anticoagulation reversalAdequate anticoagulation reversal  Patient accepts risks of bleeding,Patient accepts risks of bleeding, infection, neurological injury,infection, neurological injury, inadequate pain relief, need for revisioninadequate pain relief, need for revision surgery.surgery.
    31. 31. Serious Risk: Catheter Granulomas inSerious Risk: Catheter Granulomas in PatientsPatients  Neurosurgery. 2002 Jan;50(1):78-86;Neurosurgery. 2002 Jan;50(1):78-86; discussion 86-7. Inflammatory massdiscussion 86-7. Inflammatory mass lesions associated with intrathecal druglesions associated with intrathecal drug infusion catheters: report andinfusion catheters: report and observations on 41 patients. Coffey RJ,observations on 41 patients. Coffey RJ, Burchiel KBurchiel K  30 of the 41 underwent surgery for30 of the 41 underwent surgery for cauda equina syndrome, 11 of thesecauda equina syndrome, 11 of these were non ambulatory afterwardswere non ambulatory afterwards  Only seen with narcotic infusionOnly seen with narcotic infusion
    32. 32. Chronic IT MS InfusionsChronic IT MS Infusions Produce Significant SideProduce Significant Side Effects in SheepEffects in Sheep  MS IT sheep infusions 12-18mg/day produceMS IT sheep infusions 12-18mg/day produce inflammatory masses extending the length of theinflammatory masses extending the length of the catheter and hindlimb deficits in 2/3 of sheep. 6-catheter and hindlimb deficits in 2/3 of sheep. 6- 9mg/day produced 5cm inflammatory mass;9mg/day produced 5cm inflammatory mass; 3mg/day produced no inflammation.3mg/day produced no inflammation. Anesthesiology. 2003 Jul;99(1):188-198. Safety ofAnesthesiology. 2003 Jul;99(1):188-198. Safety of Chronic Intrathecal Morphine Infusion in a Sheep Model.Chronic Intrathecal Morphine Infusion in a Sheep Model. Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,Gradert TL, Baze WB, Satterfield WC, Hildebrand KR, Johansen MJ, Hassenbusch SJ.Johansen MJ, Hassenbusch SJ.
    33. 33. Tolerance is the Norm-ITTolerance is the Norm-IT Infusions Do Not Eliminate theInfusions Do Not Eliminate the Need for Escalating DosesNeed for Escalating Doses  Mean MS dosing increased from 1.2mg toMean MS dosing increased from 1.2mg to 5.1mg after 24 months5.1mg after 24 months J Pain Symptom Manage.J Pain Symptom Manage. 2001 Oct;22(4):862-71. Long-term intrathecal infusion of2001 Oct;22(4):862-71. Long-term intrathecal infusion of drug combinations for chronic back and leg pain.drug combinations for chronic back and leg pain.  Mean MS dosing increased from 1.1 mg toMean MS dosing increased from 1.1 mg to 3.1mg after 6 months3.1mg after 6 months Surg Neurol. 2001Surg Neurol. 2001 Feb;55(2):79-86; discussion 86-8. Continuous intrathecalFeb;55(2):79-86; discussion 86-8. Continuous intrathecal morphine treatment for chronic pain of nonmalignantmorphine treatment for chronic pain of nonmalignant etiology: long-term benefits and efficacy. Kumar K, Kellyetiology: long-term benefits and efficacy. Kumar K, Kelly M, Pirlot T.M, Pirlot T.
    34. 34. NeuraxialNeuraxial ScreeningScreening TrialsTrials
    35. 35. There Are Mixed Signals as to What Constitutes the Most Appropriate Intrathecal Trial
    36. 36. Screening TrialsScreening Trials  Last step in patient selection processLast step in patient selection process  Performed by admin. Intraspinal MS,Performed by admin. Intraspinal MS, hydromorphone, or sufenta via lumbar puncturehydromorphone, or sufenta via lumbar puncture or percutaneous catheteror percutaneous catheter  Bolus or continuous infusionBolus or continuous infusion  Paice et al.> Most common:continuous epiduralPaice et al.> Most common:continuous epidural infusion (35.3%), intrathecal bolus (33.7%),infusion (35.3%), intrathecal bolus (33.7%), bolus epidural (24.5%). Least common:bolus epidural (24.5%). Least common: continuous intrathecal infusion 6%continuous intrathecal infusion 6%  Paice JA, Penn RD, Shott S. Intraspinal morphine for chronic pain: a retrospective, multi-centerPaice JA, Penn RD, Shott S. Intraspinal morphine for chronic pain: a retrospective, multi-center study. J Pain symptom managementstudy. J Pain symptom management 19961996;11:71-80.;11:71-80.
    37. 37. Purpose of TrialingPurpose of Trialing  Eliminate placebo effectEliminate placebo effect  Access side effect profileAccess side effect profile  Determine optimal starting dosagesDetermine optimal starting dosages  Provide satisfactory responseProvide satisfactory response
    38. 38. Satisfactory Patient Response is the Most Important Element of the Trial
    39. 39. Other Purposes of the TrialOther Purposes of the Trial  Allow the Physician to Observe the PatientAllow the Physician to Observe the Patient ResponseResponse  Permits the patient to experience thePermits the patient to experience the feeling of intrathecal infusion and sidefeeling of intrathecal infusion and side effectseffects
    40. 40. Medical-legal: Appropriate trials can reduce the risk of having to swim with the sharks later
    41. 41. Advantages &Advantages & Disadvantages IT/EpiduralDisadvantages IT/Epidural  AdvantagesAdvantages  IntrathecalIntrathecal  Replicates system to beReplicates system to be implantedimplanted  Better predictor ofBetter predictor of efficacyefficacy  EpiduralEpidural  Less invasiveLess invasive  No post dural punctureNo post dural puncture headacheheadache  Less chance ofLess chance of meningitismeningitis  DisadvantagesDisadvantages  IntrathecalIntrathecal  Risk of postdural punctureRisk of postdural puncture headacheheadache  More invasiveMore invasive  Risk of spinal-cutaneous fistulaRisk of spinal-cutaneous fistula  EpiduralEpidural  May observe more adverseMay observe more adverse events due to higher doseevents due to higher dose  Potency of epidural opioids isPotency of epidural opioids is less than for intrathecal opioidsless than for intrathecal opioids  Systemic absorption verySystemic absorption very highhigh
    42. 42. Screening Trials CriteriaScreening Trials Criteria  Not have benefited satisfactorily with optimalNot have benefited satisfactorily with optimal medical managementmedical management  More conservative measures ruled outMore conservative measures ruled out  Different methods available but shouldDifferent methods available but should addressaddress::  Does the patient have side effects with theDoes the patient have side effects with the administered drug that wouldadministered drug that would contraindicate the therapy?contraindicate the therapy?  Does the patient demonstrate adequateDoes the patient demonstrate adequate pain relief?pain relief?
    43. 43. Screening CriteriaScreening Criteria (Tutak & Doleys)(Tutak & Doleys) I.I. At least 50% relief of pain during the trial**At least 50% relief of pain during the trial** II.II. Discontinued use of systemic narcotics duringDiscontinued use of systemic narcotics during the trialthe trial III.III. Increased activity level or decreased level ofIncreased activity level or decreased level of discomfort at typical activity leveldiscomfort at typical activity level IV.IV. Absence of untoward side effectsAbsence of untoward side effects V.V. Absence of significant psychopathologyAbsence of significant psychopathology VI.VI. Appropriate expectationsAppropriate expectations Tutak U, doleys DM: Intrathecal infusion systems for treatment of chronic low back andTutak U, doleys DM: Intrathecal infusion systems for treatment of chronic low back and leg pain of noncancer origin. Southern Medical J 89:295, 1996.leg pain of noncancer origin. Southern Medical J 89:295, 1996. ** Note Overt Withdrawal Syndrome will Occur if Oral Meds Discontinued During Sufentanil or Fentanyl Intrathecal Trials
    44. 44. ApproachesApproaches  Single Bolus (Epidural vs. intrathecal)Single Bolus (Epidural vs. intrathecal)  Multiple bolus injectionsMultiple bolus injections  PlaceboPlacebo  Epidural or intrathecalEpidural or intrathecal  CatheterCatheter  Continuous with external pump (epiduralContinuous with external pump (epidural or functional intrathecal trial)or functional intrathecal trial)
    45. 45. Catheter ScreeningCatheter Screening TechniquesTechniques  Percutaneous (Epidural & Intrathecal)Percutaneous (Epidural & Intrathecal)  Most frequently usedMost frequently used  Paramedian approachParamedian approach  Catheter placement, tunneled subcutaneouslyCatheter placement, tunneled subcutaneously  Surgical-Permanent Catheter Implanted atSurgical-Permanent Catheter Implanted at the Time of the Trialthe Time of the Trial  Avoids instrumenting the spine twiceAvoids instrumenting the spine twice  Use of second disposable tunneled catheterUse of second disposable tunneled catheter  Use only if you are really really sure...Use only if you are really really sure...
    46. 46. Patients Don’t Like Surprises (so do a good trial to prove to the patient exactly how the infusion will feel)
    47. 47. Time Trials for Potential Pump Patients:Time Trials for Potential Pump Patients: Functional Intrathecal TrialsFunctional Intrathecal Trials
    48. 48. Intrathecal Infusions (Deer et al.)Intrathecal Infusions (Deer et al.)  Oral MSO4 (Ms) dose titrated down prior toOral MSO4 (Ms) dose titrated down prior to initiationinitiation  Implanted tunneled catheter below costal marginImplanted tunneled catheter below costal margin  External pump with MSO4 @ 0.5-1.0mg/d;External pump with MSO4 @ 0.5-1.0mg/d; increased @ 1 mg/day until 50% reliefincreased @ 1 mg/day until 50% relief  Oral MS decreased 50% on first day for 3 daysOral MS decreased 50% on first day for 3 days then stoppedthen stopped  Co-medication with metoclopramide and laxativesCo-medication with metoclopramide and laxatives  Pain diary kept of VAS; successful if > 50% for 3Pain diary kept of VAS; successful if > 50% for 3 daysdays Deer T, Winkelmuller W, erdine S, Burchiel K. Intrathecal Therapy for cancer and nonmalignant pain:Deer T, Winkelmuller W, erdine S, Burchiel K. Intrathecal Therapy for cancer and nonmalignant pain: patient selection and patient management. Neuromodulation 1999;2:55-66.patient selection and patient management. Neuromodulation 1999;2:55-66.
    49. 49. Advantages of FunctionalAdvantages of Functional Intrathecal Trials (FIT)Intrathecal Trials (FIT)  Physician will know exact starting dosePhysician will know exact starting dose to be placed in intrathecal pump whichto be placed in intrathecal pump which eliminates need for post-permanenteliminates need for post-permanent implant hospitalizationimplant hospitalization  Patient knows exactly what they willPatient knows exactly what they will obtain in the way of pain reliefobtain in the way of pain relief  Outpatient IT trial is used to determineOutpatient IT trial is used to determine effects of ADL on paineffects of ADL on pain  Patients are usually opiate effectPatients are usually opiate effect toleranttolerant
    50. 50. Disadvantages of FITDisadvantages of FIT  Infection/meningitis riskInfection/meningitis risk  Post dural puncture headache 5-20%Post dural puncture headache 5-20%  Patients may not recognize significant sidePatients may not recognize significant side effectseffects  System must be closed and not re-openedSystem must be closed and not re-opened (eliminates multiple drug possibilities)(eliminates multiple drug possibilities)  Limited timeframe (Some physicians are usingLimited timeframe (Some physicians are using up to 2-4 week functional intrathecal trialsup to 2-4 week functional intrathecal trials  Use of IT sufenta during oral opiate reductionUse of IT sufenta during oral opiate reduction for the trial may induce a full blown narcoticfor the trial may induce a full blown narcotic withdrawal syndromewithdrawal syndrome
    51. 51. FIT Screening DevicesFIT Screening Devices
    52. 52. How to Conduct FIT SafelyHow to Conduct FIT Safely  Scrupulous skin preparationScrupulous skin preparation  Antibiotic IV 30-60min prior to insertion andAntibiotic IV 30-60min prior to insertion and follow-up for 10 days with antibioticfollow-up for 10 days with antibiotic  19ga wire wound epidural catheter placed19ga wire wound epidural catheter placed intrathecally-tunnel the catheterintrathecally-tunnel the catheter  Use lumbar placement unless pain isUse lumbar placement unless pain is cervical and sufenta is the opiate chosencervical and sufenta is the opiate chosen  External infusor at 0.1-2 cc/hrExternal infusor at 0.1-2 cc/hr  Superglue all connections togetherSuperglue all connections together  Average 5-7 day trial- Bolus in ORAverage 5-7 day trial- Bolus in OR
    53. 53. Fluoroscopic Placement of ITFluoroscopic Placement of IT NeedleNeedle
    54. 54. IT Catheter AdvancementIT Catheter Advancement
    55. 55. Fluoroscopic CatheterFluoroscopic Catheter PlacementPlacement
    56. 56. Incision at Needle Entry SiteIncision at Needle Entry Site
    57. 57. Stitch Placed Across IncisionStitch Placed Across Incision
    58. 58. Metal Stylette or 20ga NeedleMetal Stylette or 20ga Needle Tunneled From Incision Site LaterallyTunneled From Incision Site Laterally
    59. 59. Epidural Needle Removed thenEpidural Needle Removed then Placed End to End with StylettePlaced End to End with Stylette
    60. 60. Advance Epidural Needle Over Tip ofAdvance Epidural Needle Over Tip of Stylette to Avoid Catheter LacerationStylette to Avoid Catheter Laceration
    61. 61. Once Epidural Needle is AdvancedOnce Epidural Needle is Advanced to Central Incision, Thread Catheterto Central Incision, Thread Catheter Through the Epidural NeedleThrough the Epidural Needle
    62. 62. Catheter Buried Under SutureCatheter Buried Under Suture
    63. 63. Epidural Needle RetractedEpidural Needle Retracted
    64. 64. Central Incision Closed-Prior StitchCentral Incision Closed-Prior Stitch Placement With Protected Catheter AvoidsPlacement With Protected Catheter Avoids Pithing Catheter Later with NeedlePithing Catheter Later with Needle
    65. 65. Knot Tied In CatheterKnot Tied In Catheter
    66. 66. Catheter Loop Stitch to SkinCatheter Loop Stitch to Skin
    67. 67. Final ViewFinal View Central Incision Intrathecal Catheter
    68. 68. Dressing, Filter,Dressing, Filter, Connect toConnect to External Pump,External Pump, INSTRUCTIONSINSTRUCTIONS !!
    69. 69. There is a significant cervical-lumbarThere is a significant cervical-lumbar concentration gradient for hydrophilicconcentration gradient for hydrophilic compoundscompounds  Using hydrophilic Indium labeled DETAPA, the T2Using hydrophilic Indium labeled DETAPA, the T2 concentrations were only 42% as high as the T12concentrations were only 42% as high as the T12 concentrations after lumbar boluses in humansconcentrations after lumbar boluses in humans Neurosurgery. 1993 Aug;33(2):226-30Neurosurgery. 1993 Aug;33(2):226-30  In another study, the ratio of high cervical vs. Low thoracicIn another study, the ratio of high cervical vs. Low thoracic concentrations of morphine was 21% following a single bolus.concentrations of morphine was 21% following a single bolus. The same percentage for meperidine was 10%.The same percentage for meperidine was 10%. Anesthesiology. 1985Anesthesiology. 1985 Nov;63(5):483-9. Distribution of morphine and meperidine after intrathecal administrationNov;63(5):483-9. Distribution of morphine and meperidine after intrathecal administration in rat and mouse. Gustafsson LLin rat and mouse. Gustafsson LL  Another study demonstrated no cisternalAnother study demonstrated no cisternal methadone after lumbar injections.methadone after lumbar injections.
    70. 70. PCEA: Continuous Epidural InfusionPCEA: Continuous Epidural Infusion TrialsTrials  Arrow Flextip CatheterArrow Flextip Catheter  Outpatient vs. 23 hour stayOutpatient vs. 23 hour stay  Local anesthesia with iv sedationLocal anesthesia with iv sedation  FluoroscopyFluoroscopy  Epidurogram; contrastEpidurogram; contrast non-ionicnon-ionic ONLY!ONLY!  Cervical v Thoracic v LumbarCervical v Thoracic v Lumbar  Tip locationTip location  Tunnel catheterTunnel catheter  0.22 micron filter0.22 micron filter  Microject Infusion PCEA pumpMicroject Infusion PCEA pump
    71. 71. Outpatient ContinuousOutpatient Continuous Epidural Infusion TrialEpidural Infusion Trial  Long term 1-4 weeksLong term 1-4 weeks  Patient returned to usual , familiarPatient returned to usual , familiar environmentenvironment  Less cost $$ than inpatientLess cost $$ than inpatient  Increase specificity/selection?Increase specificity/selection?  Patient satisfactionPatient satisfaction  Greater controlGreater control  Medicare may not reimburse enough toMedicare may not reimburse enough to cover outpatient trial costscover outpatient trial costs
    72. 72. PCEA Trial Dosing and SetupPCEA Trial Dosing and Setup J Patrick Couch, MDJ Patrick Couch, MD  23hr observation/Outpatient trial23hr observation/Outpatient trial  Initial dose equivalent to daily oral doseInitial dose equivalent to daily oral dose  Reduce oral dose by 50% initially toReduce oral dose by 50% initially to prevent withdrawalprevent withdrawal  Continue oral taper by 15-20%/dayContinue oral taper by 15-20%/day  Increase infusion by 25-33% q 24 hrs untilIncrease infusion by 25-33% q 24 hrs until pain relief >50%pain relief >50%
    73. 73. ProtocolProtocol  Set initial infusion at 0.3-0.5cc/hr.Set initial infusion at 0.3-0.5cc/hr.  PCEA mode:PCEA mode:  -10%-10%  -30 min –1 hr lockout-30 min –1 hr lockout  Physician judgmentPhysician judgment  DurationDuration  1-4 weeks1-4 weeks  Antibiotic prophylaxis x 2 weeksAntibiotic prophylaxis x 2 weeks
    74. 74. Disadvantages to PCEA TrialsDisadvantages to PCEA Trials  Yaksh demonstrated in 1986 that theYaksh demonstrated in 1986 that the fraction of epidural morphine crossing thefraction of epidural morphine crossing the dura after single injections is only 0.31%dura after single injections is only 0.31% (Anesthesia & Analgesia, Vol 65, 583-592)(Anesthesia & Analgesia, Vol 65, 583-592)  There is no direct correlation betweenThere is no direct correlation between epidural and intrathecal opiate dosesepidural and intrathecal opiate doses  Major effect may be systemic sinceMajor effect may be systemic since concentrations of the systemic drug may beconcentrations of the systemic drug may be highhigh
    75. 75. Problems with Continuous EpiduralProblems with Continuous Epidural TrialsTrials  CSF and plasma MS concentrations 60 min afterCSF and plasma MS concentrations 60 min after epidural installation are equal. Concentrations in CSFepidural installation are equal. Concentrations in CSF are 4-8 times higher with epidural vs IM injectionare 4-8 times higher with epidural vs IM injection PharmacolPharmacol Res Commun. 1985 Feb;17(2):189-96.Res Commun. 1985 Feb;17(2):189-96.  Sufentanil blood levels were equal for epidural vs IVSufentanil blood levels were equal for epidural vs IV infusions with same pain controlinfusions with same pain control Anesthesiology.Anesthesiology. 1994 Aug;81(2):346-52; discussion1994 Aug;81(2):346-52; discussion  Fentanyl blood levels during continuous epiduralFentanyl blood levels during continuous epidural infusion produced a steady rise in bloodinfusion produced a steady rise in blood concentrations to produce hypoxia after 48 hours.concentrations to produce hypoxia after 48 hours. Pain control was no different than IV fentanyl infusion.Pain control was no different than IV fentanyl infusion.
    76. 76. Complications Of ContinuousComplications Of Continuous Trial Systems (FIT andTrial Systems (FIT and Epidural)Epidural) Patient Related-incompetent patients, inability toPatient Related-incompetent patients, inability to articulate pain, inability to comprehendarticulate pain, inability to comprehend instructions, risks due to patient at homeinstructions, risks due to patient at home  SurgicalSurgical  InfectionInfection  BleedingBleeding  Dural puncture headache/CSF leakDural puncture headache/CSF leak  Tissue breakdownTissue breakdown  Device-RelatedDevice-Related  System malfunctionSystem malfunction  Catheter migration/obstructionCatheter migration/obstruction  Pain caused by system placementPain caused by system placement
    77. 77. Complications of ContinuousComplications of Continuous Trial Systems (Cont’d)Trial Systems (Cont’d)  Infusate-relatedInfusate-related  Dosage miscalculationDosage miscalculation  OverdosageOverdosage CATHETER BREAKAGE CAN OCCUR ONCATHETER BREAKAGE CAN OCCUR ON REMOVAL!REMOVAL! Usually this occurs in the tunnelUsually this occurs in the tunnel and it is easy to remove the stitch from theand it is easy to remove the stitch from the spinal wound and extricate the remainingspinal wound and extricate the remaining cathetercatheter
    78. 78. Not All Trials Give the Desired Result
    79. 79. Single Bolus TrialsSingle Bolus Trials  NPO 6 hoursNPO 6 hours  Informed consentInformed consent  IV accessIV access  Bolus injection based on oral equivalent doseBolus injection based on oral equivalent dose  Monitor for 12 hours (23 hour observation) This may be waivedMonitor for 12 hours (23 hour observation) This may be waived in healthy opiate tolerant patientsin healthy opiate tolerant patients  Disadvantages: 1. High concentrations opiates may produceDisadvantages: 1. High concentrations opiates may produce side effects, but it is not certain these will abate over time afterside effects, but it is not certain these will abate over time after implant 2. Lack of continuous infusion does not adequatelyimplant 2. Lack of continuous infusion does not adequately test real life conditions, insidious side effects such as pedaltest real life conditions, insidious side effects such as pedal edema, severe constipation, sedation 3. Patient cannot detectedema, severe constipation, sedation 3. Patient cannot detect problems with either pain control nor side effects when not atproblems with either pain control nor side effects when not at steady statesteady state
    80. 80. Effect of IT vs IV MS on VentilatoryEffect of IT vs IV MS on Ventilatory Response to HypoxiaResponse to Hypoxia NEJMVolume 343:1228-1234 October 26, 2000NEJMVolume 343:1228-1234 October 26, 2000 0 5 10 15 20 25 30 35 40 45 Placebo MS IT 30 min 12 hrs  MS IV dose wasMS IV dose was 0.14mg/kg0.14mg/kg  MS IT dose was 0.3MS IT dose was 0.3 mg/kgmg/kg  12 hour respiratory12 hour respiratory depression remaineddepression remained significantsignificant  HoweverHowever, these were, these were not opiate tolerantnot opiate tolerant patientspatients Liters/min
    81. 81. Predictive Value of Single ShotPredictive Value of Single Shot Intrathecal Opiate TrialsIntrathecal Opiate Trials Pain PracticePain Practice Dec 2002Dec 2002 Dominguez, et. alDominguez, et. al  Three groups of responders: 0.25mgThree groups of responders: 0.25mg (low dose), 0.5mg (standard dose), 1mg(low dose), 0.5mg (standard dose), 1mg (biggie size) MS used or equiv.(biggie size) MS used or equiv.  Patients were followed both byPatients were followed both by diagnosis and by intrathecal dosediagnosis and by intrathecal dose escalation after implantation of pumpescalation after implantation of pump  Dose equivalencies were determinedDose equivalencies were determined using a Texas Tech IT opiateusing a Texas Tech IT opiate equivalency scaleequivalency scale
    82. 82. Dose Escalation for the 3Dose Escalation for the 3 GroupsGroups Dominguez, et al Pain Practice Dec 2002Dominguez, et al Pain Practice Dec 2002 0 5 10 15 20 25 30 35 Initial 6 mos 12 mos 18 mos 24 mos mg/day High Dose Standard Low Dose
    83. 83. Dose Escalation vs. DiseaseDose Escalation vs. Disease Dominguez, et al Pain Practice Nov 2002Dominguez, et al Pain Practice Nov 2002 0 10 20 30 40 50 60 70 Initial 6 mos 12 mos 18 mos 24 mos mg/day Cervicalgia Visceral Deafferentiation Chronic Low Back Peripheral Neuropathy
    84. 84. Prospective Randomized Trial ofProspective Randomized Trial of IT single shot vs EpiduralIT single shot vs Epidural Infusion for IT Pump ImplantInfusion for IT Pump Implant Valerie Anderson et al Neuromodulation July 2003Valerie Anderson et al Neuromodulation July 2003  67% of IT single shot patients had67% of IT single shot patients had relief>50% and underwent implantrelief>50% and underwent implant  79% of CEI patients had relief >50% and79% of CEI patients had relief >50% and underwent implantationunderwent implantation  6 month successful pain relief was 60% in6 month successful pain relief was 60% in both groupsboth groups  No difference in pain rating, quality of life,No difference in pain rating, quality of life, mood, or function after 6 monthsmood, or function after 6 months {37 patients total in trial}
    85. 85. The Dark Side of TrialsThe Dark Side of Trials
    86. 86. Complications RatesComplications Rates (Dahm et al.)(Dahm et al.)  Epidural vs. IntrathecalEpidural vs. Intrathecal  No difference re. Skin breakdown or local infxn.No difference re. Skin breakdown or local infxn.  Deep infectionsDeep infections  -epidural 6%-epidural 6%  -intrathecal 1%-intrathecal 1%  Catheter dislodgement, leakage and obstructionCatheter dislodgement, leakage and obstruction was sig. Higher in the epidural groupwas sig. Higher in the epidural group  Meningitis rare in epidural trials, more commonMeningitis rare in epidural trials, more common in intrathecal trialsin intrathecal trials  Dahm P, NitescuP, Appelgren L, et al. Efficacy and technical complications of long-termDahm P, NitescuP, Appelgren L, et al. Efficacy and technical complications of long-term continuous intraspinal infusions of opioid and/or bupivicaine in refractory nonmalignant pain: acontinuous intraspinal infusions of opioid and/or bupivicaine in refractory nonmalignant pain: a comparison between the epidural and the intrathecal approach with externalized or implantedcomparison between the epidural and the intrathecal approach with externalized or implanted catheters and infusion pumps.catheters and infusion pumps. Clin j PainClin j Pain 14:4-16, 1998.14:4-16, 1998.
    87. 87. Surgical TechniquesSurgical Techniques
    88. 88. Key Issues of SurgicalKey Issues of Surgical TechniqueTechnique  PlanningPlanning  What to implant (i.e., type of device)What to implant (i.e., type of device)  Where to implant itWhere to implant it  PreparationPreparation  Asepsis and antibioticsAsepsis and antibiotics  PerformancePerformance  IncisionIncision  DissectionDissection  ClosureClosure
    89. 89. Intrathecal Infusion PumpIntrathecal Infusion Pump ConsiderationsConsiderations  Programmable vs Non ProgrammableProgrammable vs Non Programmable  Differing reservoir sizes (chronic non-malignantDiffering reservoir sizes (chronic non-malignant pain- usually the larger the better)pain- usually the larger the better)  Pump morphology: Codman is flying saucerPump morphology: Codman is flying saucer shape, Medtronics is cylindricalshape, Medtronics is cylindrical  Anchoring Loops vs no loopsAnchoring Loops vs no loops  Catheter access port vs none (Catheter access port vs none (alwaysalways use ause a pump with a catheter access port for chronicpump with a catheter access port for chronic non-malignant pain)non-malignant pain)  Cost: Programmable costs 40-90% more thanCost: Programmable costs 40-90% more than non-programmable- Refill costs considerationsnon-programmable- Refill costs considerations
    90. 90. 50cc, 30cc, 16cc 0.3-2cc/day 28cc-0.4cc/day 18cc, 10cc 20, 35, 60cc 0.3, 0.5, 1.0, 1.5, 4cc/day “Know Thy Pumps” Michael 5:15 20cc, 40cc
    91. 91. Decision Making Algorithm on PumpDecision Making Algorithm on Pump LocationLocation Morbid Obesity Normal Hypersthenic Anatomic Preclusion to Implant: Colostomy, Planned abdominal surgery, severe scar tissue, etc YesNo Consider Posterior Implant Lateral Sleeper Supine Sleeper Contralateral Abdominal Wall Implantation Right Abdominal Wall Implantation Consider small Pump or submuscular Fascia implant anteriorly Contralateral abdomen Implant, posterior Implant, or possibly small pump in thigh After the above, have patient show where they would like the pump
    92. 92. Catheter Placement ConsiderationsCatheter Placement Considerations  Granuloma formation withGranuloma formation with catheter tip in the thoracic spine iscatheter tip in the thoracic spine is a real and potentially devastatinga real and potentially devastating possibilitypossibility  Location of pain: cervical,Location of pain: cervical, thoracic, lumbar, abdominal,thoracic, lumbar, abdominal, globalglobal  For cervical tip placement, risk ofFor cervical tip placement, risk of long subarachnoid catheter fromlong subarachnoid catheter from the lumbar spine vs risk of athe lumbar spine vs risk of a cervical subarachnoid puncture.cervical subarachnoid puncture.
    93. 93. Lipophilicity of Infused ITLipophilicity of Infused IT MedicationsMedications  Lipophilicity of the drug:Lipophilicity of the drug: MS 1.42MS 1.42 Baclofen1.56Baclofen1.56  Dexmedetomidine Dexmedetomidine 2.892.89 Meperidine 38 Alfentanil 130Meperidine 38 Alfentanil 130 Hydromorphone 525Hydromorphone 525 Bupivicaine 560Bupivicaine 560 Fentanyl citrate 816 Sufentanil 1727Fentanyl citrate 816 Sufentanil 1727      There were some studies demonstrating a much higher coefficient forThere were some studies demonstrating a much higher coefficient for bupivicaine (around 1500).  Values for clonidine were not found but may bebupivicaine (around 1500).  Values for clonidine were not found but may be close to dexmedetomidineclose to dexmedetomidine  Above values are octanol:water partition coefficientsAbove values are octanol:water partition coefficients
    94. 94.  No fusion in the area of lumbar needleNo fusion in the area of lumbar needle placement and lumbar catheter placement:placement and lumbar catheter placement: MAC/Spinal/GeneralMAC/Spinal/General  Fusion in area of lumbar needle placement,Fusion in area of lumbar needle placement, non-lumbar needle placement, catheternon-lumbar needle placement, catheter advancement to thoracic or cervical regions:advancement to thoracic or cervical regions: MAC for catheter advancement then GA forMAC for catheter advancement then GA for remainderremainder  TIGHT BLOOD SUGAR CONTROL DURINGTIGHT BLOOD SUGAR CONTROL DURING AND AFTER SURGERY IN DIABETICSAND AFTER SURGERY IN DIABETICS LOWERS WOUND INFECTION RATES BYLOWERS WOUND INFECTION RATES BY 66%.66%. (Endocr Pract. 2004 Mar-Apr;10 Suppl 2:21-33)(Endocr Pract. 2004 Mar-Apr;10 Suppl 2:21-33) ANESTHESIA CONSIDERATIONS:
    95. 95. Antibiotic Coverage andAntibiotic Coverage and PrepPrep  IV antibiotics (cefazolin 1g, levaquin 500mg)IV antibiotics (cefazolin 1g, levaquin 500mg) 30-30- 60 min before initial incision60 min before initial incision . DO NOT. DO NOT COMPROMISE ON THIS POINTCOMPROMISE ON THIS POINT  Everyone in the OR wears a mask on entryEveryone in the OR wears a mask on entry  Surgical hand washSurgical hand wash  Surgical scrub then prepSurgical scrub then prep  Double glove for draping, then shed outer glovesDouble glove for draping, then shed outer gloves  +/- Ioban+/- Ioban  C-arm drapeC-arm drape
    96. 96. PlanningPlanning  ““Decision before incision”Decision before incision”  Select appropriate device-patient may helpSelect appropriate device-patient may help with this-give them a model preopwith this-give them a model preop  Select appropriate implant siteSelect appropriate implant site  Incision locationIncision location  Minimize scar appearanceMinimize scar appearance  Incise along “relaxed skin tension lines,” NOTIncise along “relaxed skin tension lines,” NOT across skin creasesacross skin creases  Minimize interference with functionMinimize interference with function  Locate pump away from ribs and iliac crestLocate pump away from ribs and iliac crest
    97. 97. AsepsisAsepsis  Aseptic techniqueAseptic technique  Minimize handling of implanted devicesMinimize handling of implanted devices  Consider “no touch” techniqueConsider “no touch” technique (e.g., use forceps to handle catheter)(e.g., use forceps to handle catheter)  Consider “double gloving” with colorConsider “double gloving” with color underglovesundergloves  Breached surgical gloves are observed in surgicalBreached surgical gloves are observed in surgical team members in up to 30% of CSF shuntteam members in up to 30% of CSF shunt surgeriessurgeries
    98. 98. General Surgical PrinciplesGeneral Surgical Principles  Minimize tissue traumaMinimize tissue trauma Be gentle (Do unto others as you would haveBe gentle (Do unto others as you would have them do unto you)them do unto you)  Use appropriate size instrumentsUse appropriate size instruments  Grasp skin edges gentlyGrasp skin edges gently (dermis, not epidermis)(dermis, not epidermis)  Achieve careful hemostasisAchieve careful hemostasis  Bleeding reduces visibility, promotes infection,Bleeding reduces visibility, promotes infection, delays healing- but do not use electrocauterydelays healing- but do not use electrocautery excessivelyexcessively
    99. 99. IncisionIncision K. Follette, MDK. Follette, MD  Hold knife however you prefer but inciseHold knife however you prefer but incise perpendicular to skinperpendicular to skin From Sherris and Kerns, Basic Surgical Skills, 1999
    100. 100. Incision and DissectionIncision and Dissection K Follett, MDK Follett, MD  Know your tissue layersKnow your tissue layers Pump pocket goes here Anchors go here
    101. 101. ClosureClosure  For best closure, select appropriateFor best closure, select appropriate sutures and needlessutures and needles  Tapered needle for “soft” tissuesTapered needle for “soft” tissues  ““Cutting” needle for “firm” tissueCutting” needle for “firm” tissue (e.g., skin)(e.g., skin) From Sherris and Kerns, Basic Surgical Skills, 1999
    102. 102. SuturesSutures  Types of sutureTypes of suture  Absorbable 120 day or less strengthAbsorbable 120 day or less strength  Minimal long-term inflammatory responseMinimal long-term inflammatory response  Lower infection risk?Lower infection risk?  Non-absorbable (may last many years)Non-absorbable (may last many years)  Greater longevity (e.g., for anchors and connecting parts)Greater longevity (e.g., for anchors and connecting parts)  BraidedBraided  Easy to tie, holds knotsEasy to tie, holds knots  MonofilamentMonofilament  Lower risk of infection?Lower risk of infection?  More difficult to tieMore difficult to tie
    103. 103. Suture MaterialsSuture Materials From Sherris and Kerns, Basic Surgical Skills, 1999
    104. 104. Staying Power of SuturesStaying Power of Sutures
    105. 105. Suture MaterialsSuture Materials From Sherris and Kerns, Basic Surgical Skills, 1999
    106. 106. Time after surgery (weeks) 0 6 %normaltissuestrength 100 suture strengthtissue strength total wound strength Suture must provide wound strength until tissue heals
    107. 107. Infection Risk of SutureInfection Risk of Suture
    108. 108. ClosureClosure  TechniqueTechnique  Obliterate dead space (pocket should holdObliterate dead space (pocket should hold pump without tension but not be too large)pump without tension but not be too large)  Undermine to reduce tension on skin closureUndermine to reduce tension on skin closure  Approximate skin edges to promote healingApproximate skin edges to promote healing and minimize infection and wound breakdownand minimize infection and wound breakdown riskrisk  Approximate, don’t strangulate !Approximate, don’t strangulate !
    109. 109. Deep ClosureDeep Closure From Sherris and Kerns, Basic Surgical Skills, 1999
    110. 110. Skin ClosureSkin Closure From Sherris and Kerns, Basic Surgical Skills, 1999 Approximate, don’t strangulate
    111. 111. Surgical InstrumentsSurgical Instruments Gelpi Retractor Weitlander Retractor Adson Toothed Forceps DeBakey Forceps (No teeth) Curved Metzenbaum Dissecting Scissors “Metz” Kocher Clamp With Teeth Mayo Scissors Mosquito Hemostat Allis Clamp
    112. 112. Surgical SequenceSurgical Sequence  Spinal Incision midline, slight paramedian needleSpinal Incision midline, slight paramedian needle placed into CSF, thread catheter, open pump forplaced into CSF, thread catheter, open pump for prep, placement of anchor stitch +/- purse stringprep, placement of anchor stitch +/- purse string stitch in ISL, abdominal incision, pocket creationstitch in ISL, abdominal incision, pocket creation with fascial exposure, fascial non-absorbablewith fascial exposure, fascial non-absorbable anchor stitches, tunneling, remove spinal needleanchor stitches, tunneling, remove spinal needle and catheter stylette, anchor catheter.and catheter stylette, anchor catheter.  Pass catheter to abdominal wound, trim catheterPass catheter to abdominal wound, trim catheter and pass off trimmed section for measurement,and pass off trimmed section for measurement, connector application, connect and secure toconnector application, connect and secure to pump, insert pump +/- Dacron pouch, suturepump, insert pump +/- Dacron pouch, suture pump to fascia with excess catheter coiledpump to fascia with excess catheter coiled beneath pump, wound irrigation, layeredbeneath pump, wound irrigation, layered interrupted stitch closure, bolus in ORinterrupted stitch closure, bolus in OR
    113. 113. Scrupulous Sterile Technique and Draping
    114. 114. Local Anesthesia Before Incision
    115. 115. Option: If IT Access Is Anticipated to be Difficult, Use Fluoro and Place Needle First
    116. 116. Electrocautery for Hemostasis in Spread Wound: Do NOT touch epidermis with active electrocautery
    117. 117. HINT: CSF Is Easier to Obtain In the Lateral Position with 20 deg Reverse Trendelenburg
    118. 118. Advance Catheter Under Fluoroscopy And Do NOT Pull Back On a Silastic Or Soft Catheter (Shearing)
    119. 119. Epidurogram Myelogram Use Low Volumes Non-Ionic Contrast (Omnipaque or Isovue) for intraoperative myelogram. Be very careful with cervical catheter placement to use low volumes and Keep HOB elevated
    120. 120. Options: Anchor Stitch in ISL or SSL, Double Anchor Stitches, Anchor Plus Purse-string Suture
    121. 121. Use Manual Traction and Countertraction During the Incision. Pocket Length Is 1cm Longer than Pump Diameter
    122. 122. 2/3 of Pocket Is Developed Inferior to the Incision to Prevent Scar Formation Directly Over
    123. 123. Allis Clamp Used to Hold the Dermis (not the epidermis) in Preparation For Undermining the Tissues
    124. 124. Lateral Dissection with Electrosurgical Cut Is Rapid but More Hazardous than Other Techniques
    125. 125. Manual Finger Dissection Creating Pump Pocket. Other Options Include Metzenbaum or Electrocautery Dissection
    126. 126. Non-absorbable Heavy Gauge (size 0) Used To Anchor Pump to the Fascia (Ethibond)
    127. 127. Passage of Tunneling Device using Digital Contact with Tip During Advancement
    128. 128. Removing the Stylette (Hold the Catheter and Gently, Slowly Remove The Stylette Using Steady Retraction) Remove Epidural Needle Anchor to SSL or ISL
    129. 129. Passage of Catheter Through Tunneling Device
    130. 130. Free flow of CSF Should Be Seen. If Not, Aspirate to Confirm
    131. 131. Layered Closure with Interrupted Deep Layer Stitches
    132. 132. Skin Closure Is Interrupted Horizontal Mattress Stitch
    133. 133. Remove Guard To Connect Catheter
    134. 134. Secure the Pump to the Fascia with the Non-absorbable Fascial Stitches
    135. 135. Pump Should Not Be Too Tight in Pocket: If So, Remove Pump and Expand the Pocket Size Slightly. The Skin Should Close without Tension
    136. 136. Post Op CarePost Op Care  Bolus may be given in PACUBolus may be given in PACU  No immersion bathing or showering until returnNo immersion bathing or showering until return for suture or staple removalfor suture or staple removal  No bending over forward or excessive lifting untilNo bending over forward or excessive lifting until clearedcleared  Tight control at home of diabetesTight control at home of diabetes  Continued oral antibioticsContinued oral antibiotics  Contact number where physician may beContact number where physician may be reached for fever, edema, erythema, excessivereached for fever, edema, erythema, excessive drainage, nuchal rigidity, changes in mentationdrainage, nuchal rigidity, changes in mentation  Follow in office in 7 days for wound checkFollow in office in 7 days for wound check  Stop oral narcotics based on bolus timingStop oral narcotics based on bolus timing
    137. 137. Troubleshooting and Complications of Intrathecal Infusion Pumps
    138. 138. “It could be that the purpose of your life is only to serve as a warning to others”
    139. 139. Intraoperative Complications of IT Infusion Pump Implantation
    140. 140. I. Intraoperative ComplicationsI. Intraoperative Complications  Catheter SheeringCatheter Sheering  Inability to locate subarachnoid spaceInability to locate subarachnoid space (stenosis, position, etc)(stenosis, position, etc)  Intra-abdominal tunneling (into abdomen)Intra-abdominal tunneling (into abdomen)  Extremely deep fascia (anchoring issues)Extremely deep fascia (anchoring issues)  Prior surgery (may not be evident wherePrior surgery (may not be evident where fusion mass exists)fusion mass exists)  Spinal cord damage due to passage ofSpinal cord damage due to passage of catheter (cauda equina or syrinx formation)catheter (cauda equina or syrinx formation) Reg Anesth Pain Med. 2004 Nov-Dec;29(6):606-9.- syrinx referenceReg Anesth Pain Med. 2004 Nov-Dec;29(6):606-9.- syrinx reference  Catheter obstruction (kinking or tie)Catheter obstruction (kinking or tie)
    141. 141. Intraop Neurological ComplicationsIntraop Neurological Complications  Types: Root, cauda equina,Types: Root, cauda equina, spinal cordspinal cord  Incidence <1% permanentIncidence <1% permanent  Transient root irritation in up toTransient root irritation in up to 8% with some paresis in up to 8%8% with some paresis in up to 8%  Etiology: Traumatic placement ofEtiology: Traumatic placement of catheter, inability to easilycatheter, inability to easily advance catheter, high needleadvance catheter, high needle placementplacement  Survey of 519 implanters: 35Survey of 519 implanters: 35 patients with these problemspatients with these problems
    142. 142. New Major Neurological DeficitNew Major Neurological Deficit In PACUIn PACU  MRI with contrast lumbar/thoracic spine to ruleMRI with contrast lumbar/thoracic spine to rule out epidural hematoma or cord damage. Thisout epidural hematoma or cord damage. This must be done immediately.must be done immediately.  Early EMG within 2 days may be useful as aEarly EMG within 2 days may be useful as a baseline studybaseline study  Early consultation with neurosurgeon orEarly consultation with neurosurgeon or neurologist is preferredneurologist is preferred  Do not inject local anesthetics intrathecallyDo not inject local anesthetics intrathecally during the pump implant or during the trial toduring the pump implant or during the trial to avoid confusion of drug effect vs complications.avoid confusion of drug effect vs complications.
    143. 143. Pulling Back on the CatheterPulling Back on the Catheter May Produce SheerMay Produce Sheer
    144. 144. Difficulty in Accessing CSFDifficulty in Accessing CSF Tumor, spinal stenosis, etc.Tumor, spinal stenosis, etc. Myelogram blockage L2 (Tumor)
    145. 145. Extremely Deep FasciaExtremely Deep Fascia
    146. 146. Solutions:Solutions:  Use very long sutures between the pumpUse very long sutures between the pump and the fascia (0-Ethibond)and the fascia (0-Ethibond)  Use a Dacron pouch into which growsUse a Dacron pouch into which grows fibrous tissue from the body and stabilizingfibrous tissue from the body and stabilizing the pump locationthe pump location  No pouch, no sutures. Secure by makingNo pouch, no sutures. Secure by making a snug but not too tight subcutaneousa snug but not too tight subcutaneous pocket.pocket.
    147. 147. Fusion NightmaresFusion Nightmares Solutions: 1. Enter at thoracic level 2. Enter caudal level through the sacrococcygeal ligament 3. Retrograde thoracic
    148. 148. Trauma Due to CatheterTrauma Due to Catheter PassagePassage
    149. 149. Catheter kinking/separationCatheter kinking/separation Fissure in Connector Permitting Catheter Disconnection
    150. 150. Avoidance of Kinking/disconnectAvoidance of Kinking/disconnect at time of Implantationat time of Implantation Non-Kinking Titanium Wire Reinforced Cath Intraoperative Myelography Avoid overtightening or suture strangulation of catheter. Scrupulous detail at catheter connections
    151. 151. Radiocontrast ReactionsRadiocontrast Reactions  Immediate: anaphylaxisImmediate: anaphylaxis  Use non-ionic contrast only:Use non-ionic contrast only: Omnipaque 240 or 180, Isovue M.Omnipaque 240 or 180, Isovue M. Never everNever ever use conray or ionic contrast.use conray or ionic contrast.  Presentation: paresthesias, ascendingPresentation: paresthesias, ascending tonic-clonic spasms, generalizedtonic-clonic spasms, generalized seizures, respiratory compromise,seizures, respiratory compromise, metabolic acidosis, rhabdomyolysis,metabolic acidosis, rhabdomyolysis, coma, deathcoma, death  Incidence rare but take iodine allergiesIncidence rare but take iodine allergies seriouslyseriously
    152. 152. Death Due to Delayed ContrastDeath Due to Delayed Contrast Transfer Into the Brain After MovementTransfer Into the Brain After Movement of a Morbidly Obese Patient to aof a Morbidly Obese Patient to a Gurney s/p T11 Contrast PlacementGurney s/p T11 Contrast Placement
    153. 153. II. Early Complications after ImplantII. Early Complications after Implant  Epidural HematomaEpidural Hematoma  Post Operative Seroma FormationPost Operative Seroma Formation  Bleeding from abdominalBleeding from abdominal or spinal incision Local skin infectionor spinal incision Local skin infection  Edema of skin over pumpEdema of skin over pump  Wound dehiscenceWound dehiscence  Inadequate analgesiaInadequate analgesia  PDPH with CSF leakPDPH with CSF leak  CSF HygromaCSF Hygroma  Drug OverdoseDrug Overdose
    154. 154. Seroma FormationSeroma Formation  Not uncommon-serosanguinous straw coloredNot uncommon-serosanguinous straw colored  Fluctuance over intrathecal pump with edemaFluctuance over intrathecal pump with edema  No erythema, usually very little drainageNo erythema, usually very little drainage  May be quite large 200-300ccMay be quite large 200-300cc  DO NOT TAP UNLESS ABSOLUTELYDO NOT TAP UNLESS ABSOLUTELY NECESSARYNECESSARY  Compression bandage to treatCompression bandage to treat  Avoidance through not usingAvoidance through not using excessively large pocket forexcessively large pocket for pump. Measure the pump.pump. Measure the pump.  Abdominal binder on all patientsAbdominal binder on all patients
    155. 155. Seroma Fluid Aspiration
    156. 156. Wound DehiscenceWound Dehiscence  Systemic factors:Systemic factors: Age older than 65Age older than 65 years, hypoalbuminemia, obesity, uremia,years, hypoalbuminemia, obesity, uremia, malignancy, systemic infection,malignancy, systemic infection, hypertension, Cushing disease, thyroidhypertension, Cushing disease, thyroid disease, liver disease, and congestivedisease, liver disease, and congestive heart failure, tobacco use, steroids, ASAheart failure, tobacco use, steroids, ASA can predispose to wound dehiscence. thecan predispose to wound dehiscence. the risk of dehiscence.risk of dehiscence.  Inadequate surgical technique:Inadequate surgical technique: crushing of tissue, excessivecrushing of tissue, excessive electrocautery, ineffectiveelectrocautery, ineffective hemostasis, dead space in thehemostasis, dead space in the wound,wound, excessive woundexcessive wound
    157. 157. SUPERFICIAL WOUNDSUPERFICIAL WOUND INFECTION (1-10% incidence)INFECTION (1-10% incidence)
    158. 158. EDEMA Purulence ERYTHEMA
    159. 159. AVOID THIS: EXPLANTAVOID THIS: EXPLANT 65-85% of Infections associated with Pump Implants are in the Pump Pocket
    160. 160. Avoidance of Wound Infections  Do not operate with FUO or elevated WBCDo not operate with FUO or elevated WBC  Prophylactic antibiotics (eg. Cefazolin,Prophylactic antibiotics (eg. Cefazolin, Levaquin)Levaquin)  Avoid skin shaving (clip if necessary)Avoid skin shaving (clip if necessary)  Scrupulous skin prepScrupulous skin prep  Meticulous sterile techniqueMeticulous sterile technique  Approximation of skin edgesApproximation of skin edges  Avoidance of crushing skin edgesAvoidance of crushing skin edges  Minimal electrocautery use but effectiveMinimal electrocautery use but effective hemostasishemostasis  Smallest sturdy caliber of sutureSmallest sturdy caliber of suture
    161. 161. More avoidance of infectionMore avoidance of infection  Monofilament suturesMonofilament sutures  Antibiotic timed one hour before beginningAntibiotic timed one hour before beginning of procedureof procedure  Sufficiently snug closure to avoidSufficiently snug closure to avoid hematoma or seroma formationhematoma or seroma formation  Use currently recommended prophylaxisUse currently recommended prophylaxis from infectious disease in your hospitalfrom infectious disease in your hospital  Use tight control of blood sugar inUse tight control of blood sugar in diabetics pre, intra, and post op x 1 weekdiabetics pre, intra, and post op x 1 week
    162. 162. the usual suspect Some Hospitals Have A MRSA Rate Approaching 90% of All Staph Infections: Try Avoiding Implants In These Hospitals
    163. 163. Staphylococcus epidermidis
    164. 164. E. Coli
    165. 165. Treatment of InfectionTreatment of Infection  Sterile Q tip exploration of openSterile Q tip exploration of open wound...if subcutaneous layer is intact,wound...if subcutaneous layer is intact, pack wound with sterile gauze andpack wound with sterile gauze and change 2x dailychange 2x daily  If subcutaneous layer is open, then IIf subcutaneous layer is open, then I and D in the OR with a pulsationand D in the OR with a pulsation irrigation system with bacitracinirrigation system with bacitracin 50,000U per liter saline50,000U per liter saline  Culture at time of probingCulture at time of probing  Appropriate antibiotic therapyAppropriate antibiotic therapy  Explant if pocket infected or deep spinalExplant if pocket infected or deep spinal wound infectionwound infection
    166. 166. If the pump pocket is infected, explant.If the pump pocket is infected, explant. Cultures preop via pocket aspiration orCultures preop via pocket aspiration or intraoperative gram stainintraoperative gram stain
    167. 167. Post Operative Bleeding
    168. 168. Avoidance of Post OpAvoidance of Post Op BleedingBleeding Preoperatively stop anticoagulants 72-Preoperatively stop anticoagulants 72- 96 hours, NSAIDs 3-4 days; ASA,96 hours, NSAIDs 3-4 days; ASA, Plavix, Ticlid, garlic, ginsing, vit E- 10Plavix, Ticlid, garlic, ginsing, vit E- 10 days; ginko 24 hoursdays; ginko 24 hours  Dry field before closingDry field before closing  Use layered interrupted suture closureUse layered interrupted suture closure including skinincluding skin  Approximation of skin edgesApproximation of skin edges with mattress stitchwith mattress stitch
    169. 169. Treatment Post Op BleedingTreatment Post Op Bleeding  Pressure dressingPressure dressing  ReassuranceReassurance  More frequent monitoring for the terribleMore frequent monitoring for the terrible tetrad of hematoma, infection, necrosis,tetrad of hematoma, infection, necrosis, dehiscencedehiscence  May require evacuation if continuedMay require evacuation if continued expansion occursexpansion occurs
    170. 170. “Nurse Wright, when I give the signal, you slap that Band-Aid on him as fast as possible”
    171. 171. Hematoma: Early-semigelatinous Late-solid Edema, raised area, often bluish discoloration. No increased temp of wound
    172. 172. ULTRASOUND OF SUBCUTANEOUS HEMATOMA (No Pump is Present)
    173. 173. Post Dural PuncturePost Dural Puncture HeadacheHeadache  Loss of CSF at time of implant or fromLoss of CSF at time of implant or from persistent CSF leakpersistent CSF leak  Positional headache with or withoutPositional headache with or without abducens nerve traction symptomsabducens nerve traction symptoms  Incidence approx 15% severeIncidence approx 15% severe  Immitrex is a good first choiceImmitrex is a good first choice  Consider blood patch but only ifConsider blood patch but only if absolutely necessary: consider adjacentabsolutely necessary: consider adjacent space entryspace entry
    174. 174. Persistent Leaks: Spinal-CutaneousPersistent Leaks: Spinal-Cutaneous CSF LeakCSF Leak  Continued CSFContinued CSF Drainage fromDrainage from WoundWound  More CommonMore Common After OldAfter Old Spinal CatheterSpinal Catheter RemovalRemoval  Options: Time orOptions: Time or Epidural BloodEpidural Blood PatchPatch  Do Not ProbeDo Not Probe WoundWound  Lying Supine MayLying Supine May
    175. 175. CSF HygromaCSF Hygroma  Persistent CSF leak into subcutaneousPersistent CSF leak into subcutaneous tissues causing a subcutaneoustissues causing a subcutaneous collectioncollection  May be confused with seromaMay be confused with seroma  Incidence 0.5% with purse-string sutureIncidence 0.5% with purse-string suture (Naumann), 0.5%-8% without(Naumann), 0.5%-8% without  May persist 4 weeksMay persist 4 weeks  Treatment: compression dressing, tapTreatment: compression dressing, tap only if concerned about infectiononly if concerned about infection  Caudal catheter blood patch may beCaudal catheter blood patch may be helpfulhelpful
    176. 176. Early Fascial Stitch Rupture Caused Frequent Pump Rotation With Subsequent Torque At Connection and CSF Hygroma
    177. 177. Epidural hematoma T9-12 *RAPID ONSET OF Myelopathic symptoms and/or radicular symptoms *Usually within hours *Incidence <1% *Treatment: Emergent surgical decompression EPIDURAL HEMATOMA
    178. 178. IT Drug OverdoseIT Drug Overdose  Whereas there are only 4 reported cases of postWhereas there are only 4 reported cases of post intrathecal injection seizures after morphine,intrathecal injection seizures after morphine, there are many cases of improper drug dosingthere are many cases of improper drug dosing resulting in early somnolence, respiratoryresulting in early somnolence, respiratory depression, and deathdepression, and death  These may occur in the PACUThese may occur in the PACU  Do not ever permit a nurse or tech to access theDo not ever permit a nurse or tech to access the bolus port without your immediate presence andbolus port without your immediate presence and direction…nurses should absolutely never everdirection…nurses should absolutely never ever inject contrast into the bolus port, however thereinject contrast into the bolus port, however there are some currently doing this.are some currently doing this.  Check the programming personally to make sureCheck the programming personally to make sure there is no overdose when giving an initial bolus.there is no overdose when giving an initial bolus.
    179. 179. Long Term Side Effects AreLong Term Side Effects Are Possible from Intrathecal InfusionPossible from Intrathecal Infusion TherapyTherapy
    180. 180. III. Late ComplicationsIII. Late Complications  Pump Malfunction (battery depletion, cloggedPump Malfunction (battery depletion, clogged internal filter, gear 5 dysfunction, MRI exposure >internal filter, gear 5 dysfunction, MRI exposure > 1.5 Tesla, leaky access port, mis-programmed)1.5 Tesla, leaky access port, mis-programmed)  Pump migration (flipped pump or pump migrationPump migration (flipped pump or pump migration due to increased or decreased weight )due to increased or decreased weight )  Epidural abscessEpidural abscess  Catheter disconnect or kinkingCatheter disconnect or kinking  Catheter penetration (from needles or surgery)Catheter penetration (from needles or surgery)  Catheter migration (from intrathecal CSF)Catheter migration (from intrathecal CSF)  Spinal granuloma formationSpinal granuloma formation  Seeded infectionSeeded infection
    181. 181. Sudden Onset GeneralizedSudden Onset Generalized Severe Pain and WithdrawalSevere Pain and Withdrawal SymptomsSymptoms  If Recent Refill, check invoice on drugIf Recent Refill, check invoice on drug  Query program to insure is correctQuery program to insure is correct  Simultaneous Check of Reservoir VolumeSimultaneous Check of Reservoir Volume and Pump Myelogram or Indium Scanand Pump Myelogram or Indium Scan  If catheter system is intact, then do a rotorIf catheter system is intact, then do a rotor study if Indium reservoir scan above notstudy if Indium reservoir scan above not performed (takes 3 days) or in a non-performed (takes 3 days) or in a non- programmable pump perform serial residualprogrammable pump perform serial residual volume checks.volume checks. Proper Medication is Not Reaching Spinal Receptors
    182. 182. Trouble shooting: CatheterTrouble shooting: Catheter  BreakBreak  KinkKink  DisconnectionDisconnection  DislodgementDislodgement
    183. 183. Indium ScanIndium Scan  Inject 0.55 mCi ofInject 0.55 mCi of Indium 111 into pumpIndium 111 into pump reservoirreservoir  Obtain scanObtain scan  Repeat scan at 2 or 3Repeat scan at 2 or 3 daysdays Normal Indium Scan
    184. 184. Trouble shooting-CatheterTrouble shooting-Catheter Initial Leakage 3 Day
    185. 185. Trouble shootingTrouble shooting (Indium Scan)(Indium Scan) OcclusionOcclusion
    186. 186. New Severe Low Back orNew Severe Low Back or Mid Back Pain withMid Back Pain with MyelopathyMyelopathy  MRI lumbar spine to rule out epiduralMRI lumbar spine to rule out epidural abscess, new lumbar disc problem orabscess, new lumbar disc problem or spondylolisthesis, arachnoiditis, spinalspondylolisthesis, arachnoiditis, spinal cord infarction, and granuloma of thecord infarction, and granuloma of the spinespine  C-reactive protein, ESR, and CBC usefulC-reactive protein, ESR, and CBC useful
    187. 187. Epidural abscess L4-5 with disciitis Epidural Abscess: -Intense back pain midline -Slight or normal elevation of WBC -Elevated C reactive protein -MRI diagnosis
    188. 188. Inflammatory Mass (Granuloma)Inflammatory Mass (Granuloma) • Associated with highAssociated with high concentration or high doseconcentration or high dose intrathecal opioidintrathecal opioid Presentation: loss ofPresentation: loss of analgesia, new pain +/-analgesia, new pain +/- neurological deficitsneurological deficits Has not been described inHas not been described in patients receiving baclofenpatients receiving baclofen alonealone
    189. 189. Inflammatory Mass (granuloma)
    190. 190. Inflammatory MassInflammatory Mass  Recommendations for the diagnosis, treatment, and preventionRecommendations for the diagnosis, treatment, and prevention of catheter-tip granuloma formationof catheter-tip granuloma formation  DiagnosisDiagnosis  1. Document a thorough baseline evaluation.1. Document a thorough baseline evaluation.  2. Document three-dimensional location of the intrathecal2. Document three-dimensional location of the intrathecal catheter tip at implantation.catheter tip at implantation.  3. Provide attentive follow-up and remain alert to diminishing3. Provide attentive follow-up and remain alert to diminishing analgesic effects, loss of previously satisfactory pain relief,analgesic effects, loss of previously satisfactory pain relief, remarkable or unusual increases in the patients underlying pain,remarkable or unusual increases in the patients underlying pain, steep or frequent dose escalations, or neurologic symptomssteep or frequent dose escalations, or neurologic symptoms suggestive of an inflammatory mass.suggestive of an inflammatory mass.  4. Have a low threshold of performing contrast-enhanced T1-4. Have a low threshold of performing contrast-enhanced T1- weighted MRI or CT-myelography.weighted MRI or CT-myelography.   TreatmentTreatment  1. Mildly symptomatic patients can be treated conservatively by1. Mildly symptomatic patients can be treated conservatively by drug cessation through the catheter into the mass.drug cessation through the catheter into the mass.  2. Patients with severe neurologic symptoms should have a2. Patients with severe neurologic symptoms should have a neurosurgical consult and possible neurosurgical removal of theneurosurgical consult and possible neurosurgical removal of the mass.mass. Hassenbusch S et al: Management of Intrathecal Catheter-Tip Inflammatory Masses: A Consensus Statement. Pain Medicine 2002;3(4):315-323
    191. 191. Inflammatory MassInflammatory Mass Prevention 1. Consider placement of the catheter tip in the lumbar thecal sac. 2. Keep the drug dose and concentration as low as possible for as long as possible while still achieving adequate analgesia. Hassenbusch S et al: Management of Intrathecal Catheter-Tip Inflammatory Masses: A Consensus Statement. Pain Medicine 2002;3(4):315-323 In dog studies, addition of clonidine appeared to markedly reduce the incidence of inflammation due to morphine
    192. 192. Catheter Granulomas inCatheter Granulomas in PatientsPatients  Neurosurgery. 2002 Jan;50(1):78-86;Neurosurgery. 2002 Jan;50(1):78-86; discussion 86-7. Inflammatory massdiscussion 86-7. Inflammatory mass lesions associated with intrathecal druglesions associated with intrathecal drug infusion catheters: report andinfusion catheters: report and observations on 41 patients. Coffey RJ,observations on 41 patients. Coffey RJ, Burchiel KBurchiel K  30 of the 41 underwent surgery for30 of the 41 underwent surgery for cauda equina syndrome, 11 of thesecauda equina syndrome, 11 of these were non ambulatory afterwardswere non ambulatory afterwards  Only seen with narcotic infusionOnly seen with narcotic infusion
    193. 193. Chronic IT MS InfusionsChronic IT MS Infusions Produce Dose RelatedProduce Dose Related Significant Side Effects inSignificant Side Effects in SheepSheep  MS IT sheep infusions 12-18mg/day produceMS IT sheep infusions 12-18mg/day produce inflammatory masses extending the length of theinflammatory masses extending the length of the catheter and hindlimb deficits in 2/3 of sheep. 6-catheter and hindlimb deficits in 2/3 of sheep. 6- 9mg/day produced 5cm inflammatory mass;9mg/day produced 5cm inflammatory mass; 3mg/day produced no inflammation.3mg/day produced no inflammation. Anesthesiology. 2003 Jul;99(1):188-198. Safety ofAnesthesiology. 2003 Jul;99(1):188-198. Safety of Chronic Intrathecal Morphine Infusion in a Sheep Model.Chronic Intrathecal Morphine Infusion in a Sheep Model. Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,Gradert TL, Baze WB, Satterfield WC, Hildebrand KR, Johansen MJ, Hassenbusch SJ.Johansen MJ, Hassenbusch SJ.
    194. 194. IT MS Produces Motor Deficits andIT MS Produces Motor Deficits and Inflammatory Masses on the SpinalInflammatory Masses on the Spinal Cord in DogsCord in Dogs Anesthesiology. 2003 Jul;99(1):174-187. Chronically Infused Intrathecal Morphine in Dogs. Yaksh TL, Horais KA, Tozier NA, Allen JW, Rathbun M, Rossi SS, Sommer C, Meschter C, Richter PJ, Hildebrand KR. Beagles with 28 day infusions of morphine intrathecally developed motor deficits and inflammatory masses which were dependent on the amount of morphine infused. All animals with 12mg/day developed significant inflammatory masses and many had motor deficits. Allodynia developed almost immediately on initiation of infusion. Clonidine co-infusion seemed to supress the development of the inflammatory mass.
    195. 195. Pain Med. 2004 Mar;5(1):14-25. Continuous intrathecal infusion of hydromorphone: safety in the sheep model and clinical implications. Johansen MJ, Satterfield WC, Baze WB, Hildebrand KR, Gradert TL, Hassenbusch SJ. Department of Experimental Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030- 4009, USA. OBJECTIVE: To determine the safety of hydromorphone delivered by continuous intrathecal infusion via implanted delivery systems in sheep. DESIGN: Sheep implanted with intrathecal infusion systems were randomly assigned to receive either 1.5, 3, or 6 mg/day hydromorphone HCl or saline control (3 sheep/dose level) at a fixed infusion rate of 1.92 mL/day for 28-31 days. Infusions were initiated approximately 5 days after surgical implantation of the delivery systems (pumps and intrathecal catheters), and investigators were blinded to doses administered. An additional group of sheep (N=3) received hydromorphone (open label) at a dose of 12 mg/day. All animals were examined daily during drug infusion for changes in behavior and neurologic function. Cerebrospinal fluid was analyzed for protein, cytology, and hydromorphone concentration in samples collected prior to and at the end of drug infusion. The spinal cord with the catheter in situ was removed en bloc and fixed in formalin for microscopic analysis. RESULTS: All sheep receiving intrathecal hydromorphone exhibited gaiting deficits and biting behavior over the caudal lumbar area above the infusion site. Animals treated with 12 mg/day were sedate and lethargic, and exhibited repeated biting behavior over the caudal lumbar area during the study. No lesions were noted in any animal upon gross evaluation of the spinal cord. Microscopic changes were comparable between hydromorphone- and saline-treated animals with one exception. Mild inflammation 5 cm cranial to the catheter tip was present in two of three sheep receiving 12 mg/day and in one of three sheep receiving 1.5 mg/day. Mild chronic inflammation hydromorphone in the vicinity of the catheter was also presented in saline-treated animals. CONCLUSIONS: Hydromorphone was not associated with inflammatory mass formation in the sheep model. Further studies are necessary to determine whether hydromorphone is a safer alternative to morphine for continuous intrathecal infusion for the treatment of chronic pain. Copyright American Academy of Pain Medicine
    196. 196. ArachnoiditisArachnoiditis  A permanently painful condition that mayA permanently painful condition that may include loss of bowel or bladder control,include loss of bowel or bladder control, systemic effects, and motor dysfunctionsystemic effects, and motor dysfunction  More common after spine trauma, spineMore common after spine trauma, spine surgery, and contrasts.surgery, and contrasts.  Is rare in the US and is seen only on aIs rare in the US and is seen only on a small fraction of MRIssmall fraction of MRIs
    197. 197. MRI of Arachnoiditis: Clumping of nerve roots at red dot. Compare with the free nerve roots below. Open spine surgery is thought to be the number one cause of new cases of arachnoiditis today It is possible the tears of the dura seen in up to 7% of open surgeries cause this inflammation
    198. 198. Arachnoiditis Stage 1: Arachnoid Layer and Spinal Nerves become Inflamed
    199. 199. Operative Photograph: First Stage of Adhesive Arachnoiditis. Nerve roots markedly swollen.
    200. 200. Stage 2 Arachnoiditis: Scarring and adhesions begin to bind the arachnoid and start to encapsulate spinal nerves
    201. 201. Stage 3 Arachnoiditis: Calcification and hardened scar completely encapsulate nerves
    202. 202. Operative Photograph: Final stage of adhesive arachnoiditis. Appears to be an empty cavity, nerves totally encased in dense scar tissue
    203. 203. Increasing Residual VolumesIncreasing Residual Volumes and Decreasing Pain Controland Decreasing Pain Control  Internal filter occluded (eg. Meperidine atInternal filter occluded (eg. Meperidine at 100mg/cc or MS at 50-100mg/cc)100mg/cc or MS at 50-100mg/cc)  Battery Failure (Programmable Pumps)Battery Failure (Programmable Pumps)  Internal programmable pump malfunctionInternal programmable pump malfunction  Catheter occlusion (kinking)Catheter occlusion (kinking)  ?granuloma?granuloma Perform catheter study (Indium or contrast), then rotor study, then if crystallization of drug suspected, warm saline flush of fill chamber. For battery failure, pump replacement is necessary.
    204. 204. Meperidine Crystals under Microscope
    205. 205. Expected ResidualExpected Residual Volume with IncreasingVolume with Increasing PainPain  Catheter disconnect or migrationCatheter disconnect or migration  Tolerance to the drugTolerance to the drug  New or worsening disease (eg.New or worsening disease (eg. metastasis)metastasis)  With low residual volumes, infusion rateWith low residual volumes, infusion rate becomes non-linear and slows.becomes non-linear and slows. Increase drug delivery, add an adjunctive drug, change drug, earlier refill dates, consider catheter studies and disease workup if the above fails.
    206. 206. Metastatic vertebral breast cancer Osteoporotic compression fracture
    207. 207. Inability to Access PumpInability to Access Pump  Inexperience of person performing refillInexperience of person performing refill  Pump inversionPump inversion  Pump rotation in skin fold (obesity)Pump rotation in skin fold (obesity)  Seroma, hematoma, or abscess in pocketSeroma, hematoma, or abscess in pocket Fluoroscopy of pump to confirm location, possible site revision if necessary. Manual flip of pump is possible in some patients.
    208. 208. MassiveMassive WeightWeight LossLoss (Pump Is(Pump Is DisplacedDisplaced Significantly)Significantly)
    209. 209. Massive Weight GainMassive Weight Gain
    210. 210. Intrathecal Pump May Migrate Inferiorly And Rotate Into Skin Folds Making Access Difficult and May Lead to Ulceration Over Pump
    211. 211. Lower than ExpectedLower than Expected Residual VolumeResidual Volume  Pump overfill on last refillPump overfill on last refill  Partial refill: needle pulled out before refillPartial refill: needle pulled out before refill completecomplete  Malprogrammed pumpMalprogrammed pump  Primary pump malfunctionPrimary pump malfunction  Septum leakageSeptum leakage  Surreptitious patient access of pumpSurreptitious patient access of pump (Anesthesiology. 2004(Anesthesiology. 2004 Sep;101(3):807 ), J Anal Toxicol. 1999 Mar-Apr;23(2):130-3.Sep;101(3):807 ), J Anal Toxicol. 1999 Mar-Apr;23(2):130-3. Close monitoring of refill procedure, double check programming with a second individual, consideration of a fluoroscopic fill with contrast to observe septum leakage
    212. 212. Inability to Fill ReservoirInability to Fill Reservoir Initially or During Refill PeriodInitially or During Refill Period  Reservoir valve dysfunction orReservoir valve dysfunction or activationactivation  Technical problem with needleTechnical problem with needle placement in septumplacement in septum  Air injected into reservoirAir injected into reservoir  Lack of removal of prior residual fluid orLack of removal of prior residual fluid or attempted overfillattempted overfill Purge reservoir procedure during implant (pump may be too cold; removal of all reservoir contents for subsequent refills. Do NOT attempt to force fluid into the pump-this will damage the valve
    213. 213. Headache, nausea, vomitingHeadache, nausea, vomiting  If hygroma or edema along catheter is visible,If hygroma or edema along catheter is visible, consider CSF leak due to catheter migration orconsider CSF leak due to catheter migration or pericatheter leakage from dura (positionalpericatheter leakage from dura (positional headache)headache)  If there is fever and rigid neck, suspectIf there is fever and rigid neck, suspect meningitismeningitis  If none of the above, check pump programmingIf none of the above, check pump programming and pump drug being usedand pump drug being used For suspected meningitis, tap CSF through catheter, hospitalize and place on prophylactic antibiotics. For suspected CSF leakage, perform catheter study or indium study.
    214. 214. Meningitis
    215. 215. IV. Medication EffectsIV. Medication Effects  ToleranceTolerance  Loss of libidoLoss of libido  Peripheral edemaPeripheral edema  Rash/hivesRash/hives  Nausea/vomitingNausea/vomiting  SedationSedation  Weight gainWeight gain  Drug precipitationDrug precipitation  Urinary retentionUrinary retention  ConstipationConstipation  DiaphoresisDiaphoresis  GRANULOMAGRANULOMA 10-15% of Patients with Intrathecal Infusion Systems for Pain have either intolerable side effects from the medications or inadequate pain relief. Anderson et al Pain Med Vol2 #4 2001
    216. 216. Tolerance is theTolerance is the NormNorm  Mean MS dosing increased from 1.2mg toMean MS dosing increased from 1.2mg to 5.1mg after 24 months5.1mg after 24 months J Pain Symptom Manage.J Pain Symptom Manage. 2001 Oct;22(4):862-71. Long-term intrathecal infusion of2001 Oct;22(4):862-71. Long-term intrathecal infusion of drug combinations for chronic back and leg pain.drug combinations for chronic back and leg pain.  Mean MS dosing increased from 1.1 mg toMean MS dosing increased from 1.1 mg to 3.1mg after 6 months3.1mg after 6 months Surg Neurol. 2001Surg Neurol. 2001 Feb;55(2):79-86; discussion 86-8. Continuous intrathecalFeb;55(2):79-86; discussion 86-8. Continuous intrathecal morphine treatment for chronic pain of nonmalignantmorphine treatment for chronic pain of nonmalignant etiology: long-term benefits and efficacy. Kumar K, Kellyetiology: long-term benefits and efficacy. Kumar K, Kelly M, Pirlot T.M, Pirlot T.
    217. 217. ToleranceTolerance  The average increase in the amount ofThe average increase in the amount of narcotic used from month 1 to month 12narcotic used from month 1 to month 12 is a factor of 2.5 times.is a factor of 2.5 times.  Adding adjunctive meds may lessen thisAdding adjunctive meds may lessen this  Appears to be mediated by the NMDAAppears to be mediated by the NMDA receptor activation by narcoticsreceptor activation by narcotics  No evidence drug holiday or opiateNo evidence drug holiday or opiate rotation makes any differencerotation makes any difference  May consider oral magnesium andMay consider oral magnesium and NMDA antagonists, CCK agents,NMDA antagonists, CCK agents, microdose naltrexone orallymicrodose naltrexone orally
    218. 218. Hypogonadism in Males withHypogonadism in Males with Intrathecal Opiate InfusionIntrathecal Opiate Infusion 0 10 20 30 40 50 60 Testosterone Free Androgen Index LH Control IT Opiates Normal Ranges: Testosterone 9=26 nm/l, FAI 30-80, LH2-9U/L The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222
    219. 219. Hypogonadism inHypogonadism in Postmenopausal Females withPostmenopausal Females with IT Opiate InfusionsIT Opiate Infusions 0 5 10 15 20 25 30 35 40 LH FSH Controls IT Opiates The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222 Normal Values:LH>13 U/L, FSH>38 U/L
    220. 220. Percent of Patients withPercent of Patients with Significant Reduction orSignificant Reduction or Absence of LibidoAbsence of Libido 0 10 20 30 40 50 60 70 80 90 100 Males Females Pain Patient Controls IT Infusion The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222
    221. 221. Diagnostic RecommendationsDiagnostic Recommendations for Sexually Active Patientsfor Sexually Active Patients  Baseline FSH, LH in women and baselineBaseline FSH, LH in women and baseline testosterone, LH in men prior to implanttestosterone, LH in men prior to implant  One month post implant testingOne month post implant testing  Endocrinology referral when appropriateEndocrinology referral when appropriate (especially for women)(especially for women)
    222. 222. Treatment OptionsTreatment Options::  Androderm for males if the PSA is normalAndroderm for males if the PSA is normal and there is no history of prostate CA.and there is no history of prostate CA.  Injectable testosterone if above is notInjectable testosterone if above is not possiblepossible  Viagra or equivalent for both males andViagra or equivalent for both males and females if not contraindicated by otherfemales if not contraindicated by other medical conditionsmedical conditions  Consider urology consultationConsider urology consultation
    223. 223. Peripheral EdemaPeripheral Edema  Much higher incidence in patients with pre-Much higher incidence in patients with pre- existing arterial or venous vascular disease,existing arterial or venous vascular disease, DVT history, and is made much worse inDVT history, and is made much worse in patients who already have peripheral edemapatients who already have peripheral edema  6-20% incidence with IT opiate infusions6-20% incidence with IT opiate infusions  8/37 patients receiving hydromorphone IT8/37 patients receiving hydromorphone IT exhibited peripheral edema (Anderson et al)exhibited peripheral edema (Anderson et al)  Only 16% improve through opiate rotationOnly 16% improve through opiate rotation  Mechanism: release of vasopressin fromMechanism: release of vasopressin from posterior pituitary (induced by IT opiates)posterior pituitary (induced by IT opiates)
    224. 224. Treatment of Peripheral EdemaTreatment of Peripheral Edema Induced by Intrathecal OpiatesInduced by Intrathecal Opiates  DiureticsDiuretics  Elastic support stockingsElastic support stockings  Compression pumpsCompression pumps  Opiate rotation(unproven)Opiate rotation(unproven)  Discontinuation of opiates (In a smallDiscontinuation of opiates (In a small study of 23 patients, the reduction ofstudy of 23 patients, the reduction of intrathecal opiates improved peripheralintrathecal opiates improved peripheral edema)edema)Leg edema from intrathecal opiate infusions. Eur J Pain. 2000;4(4):361-5.
    225. 225. Rash/hivesRash/hives  Rare with intrathecal infusion since theRare with intrathecal infusion since the non-immunological production of hivesnon-immunological production of hives is due to mast cell degranulation due tois due to mast cell degranulation due to a direct morphine effect. However, ina direct morphine effect. However, in the CSF there are not many mast cells.the CSF there are not many mast cells.  Rashes may be due to pruritic patientRashes may be due to pruritic patient response.response.  Rash may be due to herpes reactivationRash may be due to herpes reactivation  Treatment is switching to an alternativeTreatment is switching to an alternative opiate.opiate.

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