This presentation deals with buprenorphine drug profile, from a clinical pharmacist perspective.
Summarized version of drug, including chief ADRs, interactions, and patient and health-care professional counselling tips have been mentioned.
This presentation deals with buprenorphine drug profile, from a clinical pharmacist perspective.
Summarized version of drug, including chief ADRs, interactions, and patient and health-care professional counselling tips have been mentioned.
The key to a successful Acute Pain Service is not so much the use of sophisticated drugs and high technology equipment, but an excellent organisational structure and well trained medical and nursing personnel.
To improving postoperative pain management, we need to;
- Always applies multi-modal analgesia. (get the advantages of multimodal analgesia)
- Implementation of the existing EB regarding the use of non-opioid + opioid on as needed basis.
- Use available specific evidence for optimizing multimodal pain management procedure (PROSPECT Web site).
Regional Anesthesia in the Prevention of Persistent Postsurgical PainEdward R. Mariano, MD
Persistent postsurgical pain (PPSP), or chronic pain that develops after surgery, occurs more frequently than one may expect: up to 50% after relatively common operations. For anesthesiologists, surgeons, and pain physicians, there is an urgent need to discover methods to prevent the development of PPSP which is considered one of the more dreaded adverse outcomes following elective surgery.
Referral For Invasive Procedures For Cancer Pain Dr Alison Mitchellepicyclops
Lecture given to the North British Pain Association on 16th May 2008 by Dr Alison Mitchell. In this talk, Dr Mitchell discusses the indications for referral of patients with cancer pain for invasive procedures. She describes the new interventional cancer pain service being set up in Glasgow. www.nbpa.org.uk
Evaluating the Effectiveness of Current Pain Management StrategiesWellbe
Pain management of orthopedic surgery patients is being impacted by the changes in health care regulation and reimbursement. There is a need for safer, more effective pain management pathways that can provide opportunities for early discharge without increasing the risk of readmissions or compromising outcomes.
Current pain management strategies for joint replacements, spine surgery and outpatient knee and shoulder procedures will be examined from clinical, safety, satisfaction and cost perspectives. The process of implementing and evaluating these pathways will also be discussed.
Nina Whalen will demonstrate how she evaluated, developed and improved pain management pathways for patients. These pathways include:
– Multimodal pain management for total joint and spine
– Peripheral nerve block utilization for inpatients and outpatients
– Customized pain pathways for special populations
– The use of intraoperative tissue infiltration with medications as a primary pain management strategy in joint replacement surgery
About The Speaker:
Nina Whalen, RN, APN-C, has over 30 years of experience as a nurse practitioner in orthopedic medicine. She has been involved in every phase of patient care at both the clinic and tertiary care levels. In the 1990’s she created and worked in a nurse practitioner hospital program at Presbyterian St Luke’s hospital that provided 24 hour coverage for the needs of hospitalized orthopedic surgery patients. She has worked in research and has co-authored publications in the areas of sports medicine and total joint. She is currently the manager of clinical outcomes at OrthoIndy Hospital (formerly Indiana Orthopaedic Hospital) which is a 38 bed, physician owned, orthopedic specialty hospital in Indianapolis.
The key to a successful Acute Pain Service is not so much the use of sophisticated drugs and high technology equipment, but an excellent organisational structure and well trained medical and nursing personnel.
To improving postoperative pain management, we need to;
- Always applies multi-modal analgesia. (get the advantages of multimodal analgesia)
- Implementation of the existing EB regarding the use of non-opioid + opioid on as needed basis.
- Use available specific evidence for optimizing multimodal pain management procedure (PROSPECT Web site).
Regional Anesthesia in the Prevention of Persistent Postsurgical PainEdward R. Mariano, MD
Persistent postsurgical pain (PPSP), or chronic pain that develops after surgery, occurs more frequently than one may expect: up to 50% after relatively common operations. For anesthesiologists, surgeons, and pain physicians, there is an urgent need to discover methods to prevent the development of PPSP which is considered one of the more dreaded adverse outcomes following elective surgery.
Referral For Invasive Procedures For Cancer Pain Dr Alison Mitchellepicyclops
Lecture given to the North British Pain Association on 16th May 2008 by Dr Alison Mitchell. In this talk, Dr Mitchell discusses the indications for referral of patients with cancer pain for invasive procedures. She describes the new interventional cancer pain service being set up in Glasgow. www.nbpa.org.uk
Evaluating the Effectiveness of Current Pain Management StrategiesWellbe
Pain management of orthopedic surgery patients is being impacted by the changes in health care regulation and reimbursement. There is a need for safer, more effective pain management pathways that can provide opportunities for early discharge without increasing the risk of readmissions or compromising outcomes.
Current pain management strategies for joint replacements, spine surgery and outpatient knee and shoulder procedures will be examined from clinical, safety, satisfaction and cost perspectives. The process of implementing and evaluating these pathways will also be discussed.
Nina Whalen will demonstrate how she evaluated, developed and improved pain management pathways for patients. These pathways include:
– Multimodal pain management for total joint and spine
– Peripheral nerve block utilization for inpatients and outpatients
– Customized pain pathways for special populations
– The use of intraoperative tissue infiltration with medications as a primary pain management strategy in joint replacement surgery
About The Speaker:
Nina Whalen, RN, APN-C, has over 30 years of experience as a nurse practitioner in orthopedic medicine. She has been involved in every phase of patient care at both the clinic and tertiary care levels. In the 1990’s she created and worked in a nurse practitioner hospital program at Presbyterian St Luke’s hospital that provided 24 hour coverage for the needs of hospitalized orthopedic surgery patients. She has worked in research and has co-authored publications in the areas of sports medicine and total joint. She is currently the manager of clinical outcomes at OrthoIndy Hospital (formerly Indiana Orthopaedic Hospital) which is a 38 bed, physician owned, orthopedic specialty hospital in Indianapolis.
Ems world expo pain management 11112014.handoutMichael Dailey
Acute pain management is one of the keys to quality patient care. Over the course of the last 10 years there has been a steady evolution of prehospital pain management protocols and use of different medications. Currently, we are on the verge of a national standard of care for treatment of pain in ambulances. What has changed over that time? What medications are currently being used across the country? How are these medications being given? Dr. Dailey will discuss a national dataset of pain management protocols and discuss the goals for optimal pain management for the acute pain of medical or traumatic pain in the prehospital arena.
Pregabalin is an effective and safe adjuvant for reducing chronic
post-thoracotomy pain, without significant side effects, in all age
groups and either gender. The pain relief becomes statistically
significant after three weeks of treatment and it continues till six
months. However, larger randomized and placebo-controlled trials
of longer durations are required to further validate these findings.
Deterioration of a patient can occur at any time in the patient’s journey and eventually they may need critical care intervention or worse. Hear about NHS Ayrshire & Arran’s rescue system and how their model for improvement was used to design, implement and sustain reliable care processes that facilitated a reduction in mortality rates.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
2. SLIDE INDEX
Contributions by J Patrick Couch, Elliott Krames, K Follett, J Ordia
Physician Qualifications/Clinics- Slide 4
Patient Selection- Slide 7
Neuraxial Screening Trials- Slide 34
Surgical Techniques- Slide 87
Intraoperative Complications- Slide 148
Early Postoperative Complications-Slide 161
Late Postoperative Complications-Slide 189
Medication Effects-Slide 226
Selected Outcome Studies- Slide 252
3. WE EACH HAVE OUR OWN TALENTS
Not everyone should be implanting pumps
4. Physician Qualifications/Training
Because pain medicine has no residency
program, no defined scope of practice, or no
defined standards for intrathecal pump
implantation, the qualifications are nebulous
From a practical standpoint, only full time pain
physicians or those with full time pain coverage
by other physicians qualified to implant pumps
should be implanting these devices
Surgical skills are very useful and may help
avoid or reduce complications
Some pain physicians will perform only the trial
then perform the refills for an implanting
neurosurgeon.
5. Clinic Setup
An intrathecal pump service is far more complex
than a simple block or RF service
Requirements include: FDA tracking, medication
log, access to medical records 24 hours a day in
case the patient is admitted to another institution,
nurse in charge of tracking/refills/medication
orders, 24 hour a day availability by a physician
qualified to implant pumps and manage
complications, quality assurance in intrathecal
medication sterility and expiration times, pump
refill kits, screening psych tools pre-implantation,
billing is understood, contacting patients re: refills
6. Pre-Implantation:
Conservative Measures Exhausted
High Dose Oral or Transdermal Opiates Have
Been Tried with Intractable Side Effects
Psych Screen OK
Extended Informed Consent
Insurance approval or criteria met
Appropriate venue: Medicare cannot be
implanted in an ASC
Functional Intrathecal Trial
Systems are in place for office refills, pump
tracking, physician backup for vacations
Malpractice Insurance
10. Classic Patient Selection Criteria
Seven patient selection criteria for intrathecal
pump implantation, Elliot Krames, M.D. J Pain
& Symptom Mgt., 1996:
More conservative therapies have failed
An observable pathology exists that is concordant
with the pain complaint
Further surgical intervention is not indicated
No serious untreated drug habituation exists
Psychological evaluation and clearance for
implantation has been obtained
No contraindications to implantation exist
A Screening Test has been successful
11. Considerations for Implantation
Whitworth, 2003
Medically necessary
Failure of conservative therapy
Psychologically stable
Financially feasible
Refill considerations (timing, cost)
Adequate trial
No anticipated definitive surgery
Risk/benefit ratio acceptable
Technical pump implant considerations
12. Common Indications for
Intrathecal Therapy
Chronic non-malignant pain treatment
Cancer pain treatment
Spasticity treatment
Chemotherapy administration
13. Medical Conditions That May
Respond to Intrathecal
Therapy
CRPS with spasticity or more than 1
extremity involvement
Peridural fibrosis
Neuropathic pain (less responsive)
Spasticity (s/p CVA, MS, dystonias, CP)
CNS spinal cord tumors
Central pain (poor response)
FMS (variable response-need good trial)
14. Medical Necessity Means:
Other more conservative therapies have
been tried (often for more than 2-3 mos)
Opiate/local/alpha2 responsive pain or
baclofen responsiveness of spasticity
There are no definitive surgical treatments
available
The therapy is a standard accepted and
indicated therapy for the particular
condition
15. Conservative Therapy Failure
Oral or transdermal medications (several
types) produce significant side effects of
mentation changes, hypersedation, or
inadequate pain relief. Constipation,
pruritis, urinary retention are common
features of intrathecal therapy therefore
the presence of these side effects during
oral or transdermal opiate therapy is not a
definitive indication for intrathecal therapy.
Nausea and vomiting may be improved
with IT therapy.
16. Other Failure Indicators in
Conservative Therapy
Failure to significantly affect pain when
targeted
Failure to significantly improve
functionality
Significant side effects are occurring with
conservative therapy which are intolerable
in spite of adjunctive measures
17. Some Contraindications Based
on Conservative Therapy
Observations
Patient passivity
Unwilling to participate in functional
restoration programs, injection
therapies, or psychological treatment
Excessive optimism regarding post
implant pain relief
You have become the messiah
18. Other Contraindications
Pre-existing pedal edema: edema can
become severe in 30% with intrathecal MS
infusions (Eur J Pain. 2000;4(4):361-5.
Leg edema from intrathecal opiate
infusions. Aldrete JA)
Significant systemic side effects of
transdermal, oral, or parenteral drugs of
the same type to be infused
Any underlying infection at the time of
surgery
20. Psychological Considerations
Psychological assessment: (1) exposes
psychological factors that should be
addressed in treatment; (2) suggests
specific treatments that may help resolve
psychological risk factors; (3) facilitates
patient selection for specific pain
therapies; and (4) provides clues to
evaluate the patient's response to a
screening test or treatment.
21. Important Psych Contraindications
Untreated moderate to severe depression
Severe personality disorders
Suicidal
Homicidal
Severe obsessive-compulsive
Somatization
Substance abuse
Unable to tolerate implantation of subcutaneous
pump due to self image problems or underlying
psych problems
Manipulative or chronically dissatisfied
23. Substance Abuse Issues
Cannot be defined
without a narcotic
agreement which
spells out clinic
rules for
prescribing and
violations of these
rules.
Patient induced overdose,
script alteration, threats of
legal action unless narcotics
are prescribed, and diversion
of meds are absolute issues.
Lost or stolen drugs,
positive UDS for illegal
drugs, negative UDS for
prescribed drugs, repeated
calls afterhours for drugs,
failure to keep scheduled
appts, etc. all warrant
extreme caution.
25. Marriage and IT Pumps
Dance a little before you decide to get
married
Don’t marry anyone you don’t like (divorce
of a patient with a pump is messy)
Don’t implant a pump to silence a patient
from complaining about pain: it will not.
Patients will still complain just as much
after implantation.
26. Financial Considerations
Acquisition cost to
hospitals/ASC for
pump plus catheter
ranges from $5,500 to
10,500.
Implant costs plus
trial plus acquisition
costs may exceed
$20,000
Break even point
usually does not occur
until 9-15 months
after implantation
(money savings on
oral meds)
Medicaid does not
cover pumps.
Because of the costs,
the deductable alone
can thwart
implantation
27. Do Not Implant Programmable
Pumps In Patients Who:
May not have insurance in the future
Who are anticipated to have Medicaid as
their insurer
Who do not have a demonstrated need for
programmed dosing
Who do not follow a rigid schedule every
day
Have HMO Medicare: Costs May Not Be
Covered-check with the intermediary
28. Pump Refill Considerations
Meds to refill the pump may have
acquisition costs of $20-$500 per refill
or much higher for Prialt
Pump refill kits range from $15-$35 per
refill
Shorter refill times in cancer patients
Longer refill times in those with chronic
pain on stable therapy
Pump delivery is 10% plus or minus
Transportation vs. Home Refill
29. Importance of Trial
Next to psych eval, trial is most important
feature leading to intrathecal implantation
Adequate pain reduction
Increase functionality
Lack of significant side effects
30. Acceptable Risk Ratio
Severe Pulmonary disease patients may
pose intraoperative risks but less long
term risk vs. Oral narcotics
Uncontrolled diabetes patients will not
heal from implantation.
Adequate anticoagulation reversal
Patient accepts risks of bleeding,
infection, neurological injury,
inadequate pain relief, need for revision
surgery.
31. Serious Risk: Catheter Granulomas in Patients
Neurosurgery. 2002 Jan;50(1):78-86;
discussion 86-7. Inflammatory mass
lesions associated with intrathecal drug
infusion catheters: report and
observations on 41 patients. Coffey RJ,
Burchiel K
30 of the 41 underwent surgery for
cauda equina syndrome, 11 of these
were non ambulatory afterwards
Only seen with narcotic infusion
32. Chronic IT MS Infusions
Produce Significant Side
Effects in Sheep
MS IT sheep infusions 12-18mg/day produce
inflammatory masses extending the length of
the catheter and hindlimb deficits in 2/3 of
sheep. 6-9mg/day produced 5cm inflammatory
mass; 3mg/day produced no inflammation.
Anesthesiology. 2003 Jul;99(1):188-198. Safety of
Chronic Intrathecal Morphine Infusion in a Sheep Model.
Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,
Johansen MJ, Hassenbusch SJ.
33. Tolerance is the Norm-IT
Infusions Do Not Eliminate the
Need for Escalating Doses
Mean MS dosing increased from 1.2mg to
5.1mg after 24 months J Pain Symptom Manage.
2001 Oct;22(4):862-71. Long-term intrathecal infusion of
drug combinations for chronic back and leg pain.
Mean MS dosing increased from 1.1 mg to
3.1mg after 6 months Surg Neurol. 2001
Feb;55(2):79-86; discussion 86-8. Continuous intrathecal
morphine treatment for chronic pain of nonmalignant
etiology: long-term benefits and efficacy. Kumar K, Kelly
M, Pirlot T.
36. Screening Trials
Last step in patient selection process
Performed by admin. Intraspinal MS,
hydromorphone, or sufenta via lumbar puncture
or percutaneous catheter
Bolus or continuous infusion
Paice et al.> Most common:continuous epidural
infusion (35.3%), intrathecal bolus (33.7%),
bolus epidural (24.5%). Least common:
continuous intrathecal infusion 6%
Paice JA, Penn RD, Shott S. Intraspinal morphine for chronic pain: a retrospective, multi-center
study. J Pain symptom management 1996;11:71-80.
37. Purpose of Trialing
Eliminate placebo effect
Access side effect profile
Determine optimal starting dosages
Provide satisfactory response
39. Other Purposes of the Trial
Allow the Physician to Observe the Patient
Response
Permits the patient to experience the
feeling of intrathecal infusion and side
effects
41. Advantages &
Disadvantages IT/Epidural
Advantages
Intrathecal
Replicates system to be
implanted
Better predictor of
efficacy
Epidural
Less invasive
No post dural puncture
headache
Less chance of
meningitis
Disadvantages
Intrathecal
Risk of postdural puncture
headache
More invasive
Risk of spinal-cutaneous fistula
Epidural
May observe more adverse
events due to higher dose
Potency of epidural opioids is less
than for intrathecal opioids
Systemic absorption very
high
42. Screening Trials Criteria
Not have benefited satisfactorily with optimal
medical management
More conservative measures ruled out
Different methods available but should
address:
Does the patient have side effects with the
administered drug that would
contraindicate the therapy?
Does the patient demonstrate adequate
pain relief?
43. Screening Criteria
(Tutak & Doleys)
I. At least 50% relief of pain during the trial**
II. Discontinued use of systemic narcotics during
the trial
III. Increased activity level or decreased level of
discomfort at typical activity level
IV. Absence of untoward side effects
V. Absence of significant psychopathology
VI. Appropriate expectations
Tutak U, doleys DM: Intrathecal infusion systems for treatment of chronic low back and
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. Approaches
Single Bolus (Epidural vs. intrathecal)
Multiple bolus injections
Placebo
Epidural or intrathecal
Catheter
Continuous with external pump (epidural
or functional intrathecal trial)
45. Catheter Screening
Techniques
Percutaneous (Epidural & Intrathecal)
Most frequently used
Paramedian approach
Catheter placement, tunneled subcutaneously
Surgical-Permanent Catheter Implanted at
the Time of the Trial
Avoids instrumenting the spine twice
Use of second disposable tunneled catheter
Use only if you are really really sure...
47. Time Trials for Potential Pump Patients:
Functional Intrathecal Trials
48. Intrathecal Infusions (Deer et al.)
Oral MSO4 (Ms) dose titrated down prior to
initiation
Implanted tunneled catheter below costal margin
External pump with MSO4 @ 0.5-1.0mg/d;
increased @ 1 mg/day until 50% relief
Oral MS decreased 50% on first day for 3 days
then stopped
Co-medication with metoclopramide and laxatives
Pain diary kept of VAS; successful if > 50% for 3
days
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.
49. Advantages of Functional
Intrathecal Trials (FIT)
Physician will know exact starting dose
to be placed in intrathecal pump which
eliminates need for post-permanent
implant hospitalization
Patient knows exactly what they will
obtain in the way of pain relief
Outpatient IT trial is used to determine
effects of ADL on pain
Patients are usually opiate effect
tolerant
50. Disadvantages of FIT
Infection/meningitis risk
Post dural puncture headache 5-20%
Patients may not recognize significant side
effects
System must be closed and not re-opened
(eliminates multiple drug possibilities)
Limited timeframe (Some physicians are using
up to 2-4 week functional intrathecal trials
Use of IT sufenta during oral opiate reduction
for the trial may induce a full blown narcotic
withdrawal syndrome
52. How to Conduct FIT Safely
Scrupulous skin preparation
Antibiotic IV 30-60min prior to insertion and
follow-up for 10 days with antibiotic
19ga wire wound epidural catheter placed
intrathecally-tunnel the catheter
Use lumbar placement unless pain is
cervical and sufenta is the opiate chosen
External infusor at 0.1-2 cc/hr
Superglue all connections together
Average 5-7 day trial- Bolus in OR
69. There is a significant cervical-lumbar
concentration gradient for hydrophilic
compounds
Using hydrophilic Indium labeled DETAPA, the T2
concentrations were only 42% as high as the T12
concentrations after lumbar boluses in humans
Neurosurgery. 1993 Aug;33(2):226-30
In another study, the ratio of high cervical vs. Low thoracic
concentrations of morphine was 21% following a single bolus.
The same percentage for meperidine was 10%. Anesthesiology. 1985
Nov;63(5):483-9. Distribution of morphine and meperidine after intrathecal administration
in rat and mouse. Gustafsson LL
Another study demonstrated no cisternal
methadone after lumbar injections.
70. PCEA: Continuous Epidural Infusion
Trials
Arrow Flextip Catheter
Outpatient vs. 23 hour stay
Local anesthesia with iv sedation
Fluoroscopy
Epidurogram; contrast non-ionic ONLY!
Cervical v Thoracic v Lumbar
Tip location
Tunnel catheter
0.22 micron filter
Microject Infusion PCEA pump
71. Outpatient Continuous
Epidural Infusion Trial
Long term 1-4 weeks
Patient returned to usual , familiar
environment
Less cost $$ than inpatient
Increase specificity/selection?
Patient satisfaction
Greater control
Medicare may not reimburse enough to
cover outpatient trial costs
72. PCEA Trial Dosing and Setup
J Patrick Couch, MD
23hr observation/Outpatient trial
Initial dose equivalent to daily oral dose
Reduce oral dose by 50% initially to
prevent withdrawal
Continue oral taper by 15-20%/day
Increase infusion by 25-33% q 24 hrs until
pain relief >50%
73. Protocol
Set initial infusion at 0.3-0.5cc/hr.
PCEA mode:
-10%
-30 min –1 hr lockout
Physician judgment
Duration
1-4 weeks
Antibiotic prophylaxis x 2 weeks
74. Disadvantages to PCEA Trials
Yaksh demonstrated in 1986 that the
fraction of epidural morphine crossing the
dura after single injections is only 0.31%
(Anesthesia & Analgesia, Vol 65, 583-592)
There is no direct correlation between
epidural and intrathecal opiate doses
Major effect may be systemic since
concentrations of the systemic drug may be
high
75. Problems with Continuous Epidural
Trials
CSF and plasma MS concentrations 60 min after
epidural installation are equal. Concentrations in CSF
are 4-8 times higher with epidural vs IM injection
Pharmacol Res Commun. 1985 Feb;17(2):189-96.
Sufentanil blood levels were equal for epidural vs IV
infusions with same pain control Anesthesiology.
1994 Aug;81(2):346-52; discussion
Fentanyl blood levels during continuous epidural
infusion produced a steady rise in blood
concentrations to produce hypoxia after 48 hours.
Pain control was no different than IV fentanyl infusion.
76. Complications Of Continuous
Trial Systems (FIT and Epidural)
Patient Related-incompetent patients, inability to
articulate pain, inability to comprehend
instructions, risks due to patient at home
Surgical
Infection
Bleeding
Dural puncture headache/CSF leak
Tissue breakdown
Device-Related
System malfunction
Catheter migration/obstruction
Pain caused by system placement
77. Complications of Continuous
Trial Systems (Cont’d)
Infusate-related
Dosage miscalculation
Overdosage
CATHETER BREAKAGE CAN OCCUR ON
REMOVAL! Usually this occurs in the tunnel
and it is easy to remove the stitch from the
spinal wound and extricate the remaining
catheter
79. Single Bolus Trials
NPO 6 hours
Informed consent
IV access
Bolus injection based on oral equivalent dose
Monitor for 12 hours (23 hour observation) This may be waived
in healthy opiate tolerant patients
Disadvantages: 1. High concentrations opiates may produce
side effects, but it is not certain these will abate over time after
implant 2. Lack of continuous infusion does not adequately
test real life conditions, insidious side effects such as pedal
edema, severe constipation, sedation 3. Patient cannot detect
problems with either pain control nor side effects when not at
steady state
80. Effect of IT vs IV MS on Ventilatory
Response to Hypoxia
NEJMVolume 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 was
0.14mg/kg
MS IT dose was 0.3
mg/kg
12 hour respiratory
depression remained
significant
However, these were
not opiate tolerant
patients
Liters/min
81. Predictive Value of Single Shot
Intrathecal Opiate Trials Pain Practice Dec
2002
Dominguez, et. al
Three groups of responders: 0.25mg
(low dose), 0.5mg (standard dose),
1mg (biggie size) MS used or equiv.
Patients were followed both by
diagnosis and by intrathecal dose
escalation after implantation of pump
Dose equivalencies were determined
using a Texas Tech IT opiate
equivalency scale
82. Dose Escalation for the 3
Groups
Dominguez, 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. Dose Escalation vs. Disease
Dominguez, 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. Prospective Randomized Trial of
IT single shot vs Epidural
Infusion for IT Pump Implant
Valerie Anderson et al Neuromodulation July 2003
67% of IT single shot patients had
relief>50% and underwent implant
79% of CEI patients had relief >50% and
underwent implantation
6 month successful pain relief was 60% in
both groups
No difference in pain rating, quality of life,
mood, or function after 6 months
{37 patients total in trial}
86. Complications Rates
(Dahm et al.)
Epidural vs. Intrathecal
No difference re. Skin breakdown or local infxn.
Deep infections
-epidural 6%
-intrathecal 1%
Catheter dislodgement, leakage and obstruction
was sig. Higher in the epidural group
Meningitis rare in epidural trials, more common
in intrathecal trials
Dahm 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: a comparison
between the epidural and the intrathecal approach with externalized or implanted catheters and
infusion pumps. Clin j Pain 14:4-16, 1998.
88. Key Issues of Surgical Technique
Planning
What to implant (i.e., type of device)
Where to implant it
Preparation
Asepsis and antibiotics
Performance
Incision
Dissection
Closure
89. Intrathecal Infusion Pump
Considerations
Programmable vs Non Programmable
Differing reservoir sizes (chronic non-malignant
pain- usually the larger the better)
Pump morphology: Codman is flying saucer
shape, Medtronics is cylindrical
Anchoring Loops vs no loops
Catheter access port vs none (always use a
pump with a catheter access port for chronic
non-malignant pain)
Cost: Programmable costs 40-90% more than
non-programmable- Refill costs considerations
91. Decision Making Algorithm on Pump
Location
Morbid Obesity Normal Hypersthenic
Anatomic Preclusion to Implant: Colostomy, Planned abdominal surgery,
severe scar tissue, etc
Yes
No
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. Catheter Placement Considerations
Granuloma formation with
catheter tip in the thoracic spine
is a real and potentially
devastating possibility
Location of pain: cervical,
thoracic, lumbar, abdominal,
global
For cervical tip placement, risk of
long subarachnoid catheter from
the lumbar spine vs risk of a
cervical subarachnoid puncture.
93. Lipophilicity of Infused IT
Medications
Lipophilicity of the drug:
MS 1.42 Baclofen1.56 Dexmedetomidine 2.89
Meperidine 38 Alfentanil 130
Hydromorphone 525 Bupivicaine 560
Fentanyl citrate 816 Sufentanil 1727
There were some studies demonstrating a much higher coefficient for
bupivicaine (around 1500). Values for clonidine were not found but may be
close to dexmedetomidine
Above values are octanol:water partition coefficients
94. No fusion in the area of lumbar needle
placement and lumbar catheter placement:
MAC/Spinal/General
Fusion in area of lumbar needle placement,
non-lumbar needle placement, catheter
advancement to thoracic or cervical regions:
MAC for catheter advancement then GA for
remainder
TIGHT BLOOD SUGAR CONTROL DURING AND
AFTER SURGERY IN DIABETICS LOWERS
WOUND INFECTION RATES BY 66%. (Endocr Pract.
2004 Mar-Apr;10 Suppl 2:21-33)
ANESTHESIA CONSIDERATIONS:
95. Antibiotic Coverage and
Prep
IV antibiotics (cefazolin 1g, levaquin 500mg)
30-60 min before initial incision. DO NOT
COMPROMISE ON THIS POINT
Everyone in the OR wears a mask on entry
Surgical hand wash
Surgical scrub then prep
Double glove for draping, then shed outer gloves
+/- Ioban
C-arm drape
96. Planning
“Decision before incision”
Select appropriate device-patient may help
with this-give them a model preop
Select appropriate implant site
Incision location
Minimize scar appearance
Incise along “relaxed skin tension lines,” NOT
across skin creases
Minimize interference with function
Locate pump away from ribs and iliac crest
97. Asepsis
Aseptic technique
Minimize handling of implanted devices
Consider “no touch” technique
(e.g., use forceps to handle catheter)
Consider “double gloving” with color
undergloves
Breached surgical gloves are observed in surgical
team members in up to 30% of CSF shunt
surgeries
98. General Surgical Principles
Minimize tissue trauma
Be gentle (Do unto others as you would have
them do unto you)
Use appropriate size instruments
Grasp skin edges gently
(dermis, not epidermis)
Achieve careful hemostasis
Bleeding reduces visibility, promotes infection,
delays healing- but do not use electrocautery
excessively
99. Incision
K. Follette, MD
Hold knife however you prefer but incise
perpendicular to skin
From Sherris and Kerns, Basic Surgical Skills, 1999
100. Incision and Dissection
K Follett, MD
Know your tissue layers
Pump
pocket goes
here
Anchors
go here
101. Closure
For best closure, select appropriate
sutures and needles
Tapered needle for “soft” tissues
“Cutting” needle for “firm” tissue
(e.g., skin)
From Sherris and Kerns, Basic Surgical Skills, 1999
102. Sutures
Types of suture
Absorbable 120 day or less strength
Minimal long-term inflammatory response
Lower infection risk?
Non-absorbable (may last many years)
Greater longevity (e.g., for anchors and connecting parts)
Braided
Easy to tie, holds knots
Monofilament
Lower risk of infection?
More difficult to tie
106. Time after surgery (weeks)
0 6
%
normal
tissue
strength
100
suture strength
tissue strength
total wound strength
Suture must provide wound strength until tissue heals
108. Closure
Technique
Obliterate dead space (pocket should hold
pump without tension but not be too large)
Undermine to reduce tension on skin closure
Approximate skin edges to promote healing
and minimize infection and wound breakdown
risk
Approximate, don’t strangulate !
112. Surgical Sequence
Spinal Incision midline, slight paramedian needle
placed into CSF, thread catheter, open pump for
prep, placement of anchor stitch +/- purse string
stitch in ISL, abdominal incision, pocket creation
with fascial exposure, fascial non-absorbable
anchor stitches, tunneling, remove spinal needle
and catheter stylette, anchor catheter.
Pass catheter to abdominal wound, trim catheter
and pass off trimmed section for measurement,
connector application, connect and secure to
pump, insert pump +/- Dacron pouch, suture
pump to fascia with excess catheter coiled
beneath pump, wound irrigation, layered
interrupted stitch closure, bolus in OR
120. HINT: CSF Is Easier to Obtain In the
Lateral Position with 20 deg Reverse
Trendelenburg
121. Advance Catheter Under Fluoroscopy
And Do NOT Pull Back On a Silastic
Or Soft Catheter (Shearing)
122. 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
123. Options: Anchor Stitch in ISL or SSL, Double Anchor
Stitches, Anchor Plus Purse-string Suture
124.
125. Use Manual Traction and
Countertraction During the
Incision. Pocket Length Is 1cm
Longer than Pump Diameter
126. 2/3 of Pocket Is Developed
Inferior to the Incision to
Prevent Scar Formation
Directly Over Fill Port
127. Allis Clamp Used to Hold the Dermis
(not the epidermis) in Preparation
For Undermining the Tissues
128. Lateral Dissection with Electrosurgical Cut
Is Rapid but More Hazardous than Other
Techniques
129. Manual Finger Dissection Creating
Pump Pocket. Other Options Include
Metzenbaum or Electrocautery
Dissection
133. Removing the Stylette
(Hold the
Catheter and Gently,
Slowly Remove
The Stylette Using
Steady Retraction)
Remove Epidural Needle
Anchor to SSL or ISL
142. Pump Should Not Be Too Tight in Pocket:
If So, Remove Pump and Expand the
Pocket Size Slightly. The Skin Should
Close without Tension
143.
144. Post Op Care
Bolus may be given in PACU
No immersion bathing or showering until return
for suture or staple removal
No bending over forward or excessive lifting until
cleared
Tight control at home of diabetes
Continued oral antibiotics
Contact number where physician may be
reached for fever, edema, erythema, excessive
drainage, nuchal rigidity, changes in mentation
Follow in office in 7 days for wound check
Stop oral narcotics based on bolus timing
148. I. Intraoperative Complications
Catheter Sheering
Inability to locate subarachnoid space
(stenosis, position, etc)
Intra-abdominal tunneling (into abdomen)
Extremely deep fascia (anchoring issues)
Prior surgery (may not be evident where
fusion mass exists)
Spinal cord damage due to passage of
catheter (cauda equina or syrinx formation)
Reg Anesth Pain Med. 2004 Nov-Dec;29(6):606-9.- syrinx reference
Catheter obstruction (kinking or tie)
149. Intraop Neurological Complications
Types: Root, cauda equina, spinal
cord
Incidence <1% permanent
Transient root irritation in up to
8% with some paresis in up to 8%
Etiology: Traumatic placement of
catheter, inability to easily
advance catheter, high needle
placement
Survey of 519 implanters: 35
patients with these problems
150. New Major Neurological Deficit
In PACU
MRI with contrast lumbar/thoracic spine to rule
out epidural hematoma or cord damage. This
must be done immediately.
Early EMG within 2 days may be useful as a
baseline study
Early consultation with neurosurgeon or
neurologist is preferred
Do not inject local anesthetics intrathecally
during the pump implant or during the trial to
avoid confusion of drug effect vs complications.
154. Solutions:
Use very long sutures between the pump
and the fascia (0-Ethibond)
Use a Dacron pouch into which grows
fibrous tissue from the body and
stabilizing the pump location
No pouch, no sutures. Secure by making
a snug but not too tight subcutaneous
pocket.
158. Avoidance of Kinking/disconnect
at time of Implantation
Non-Kinking Titanium
Wire Reinforced Cath Intraoperative
Myelography
Avoid overtightening
or suture strangulation of
catheter. Scrupulous
detail at catheter
connections
159. Radiocontrast Reactions
Immediate: anaphylaxis
Use non-ionic contrast only:
Omnipaque 240 or 180, Isovue M.
Never ever use conray or ionic contrast.
Presentation: paresthesias, ascending
tonic-clonic spasms, generalized
seizures, respiratory compromise,
metabolic acidosis, rhabdomyolysis,
coma, death
Incidence rare but take iodine allergies
seriously
160. Death Due to Delayed Contrast Transfer
Into the Brain After Movement of a
Morbidly Obese Patient to a Gurney s/p
T11 Contrast Placement
161. II. Early Complications after Implant
Epidural Hematoma
Post Operative Seroma Formation
Bleeding from abdominal
or spinal incision Local skin infection
Edema of skin over pump
Wound dehiscence
Inadequate analgesia
PDPH with CSF leak
CSF Hygroma
Drug Overdose
162. Seroma Formation
Not uncommon-serosanguinous straw colored
Fluctuance over intrathecal pump with edema
No erythema, usually very little drainage
May be quite large 200-300cc
DO NOT TAP UNLESS ABSOLUTELY NECESSARY
Compression bandage to treat
Avoidance through not using
excessively large pocket for
pump. Measure the pump.
Abdominal binder on all patients
164. Wound Dehiscence
Systemic factors: Age older than 65
years, hypoalbuminemia, obesity, uremia,
malignancy, systemic infection,
hypertension, Cushing disease, thyroid
disease, liver disease, and congestive
heart failure, tobacco use, steroids, ASA
can predispose to wound dehiscence. the
risk of dehiscence.
Inadequate surgical technique:
crushing of tissue, excessive
electrocautery, ineffective
hemostasis, dead space in the
wound, excessive wound
tension, and overly tight sutures.
168. AVOID THIS: EXPLANT NECESSARY
65-85% of Infections associated with Pump
Implants are in the Pump Pocket
169. Avoidance of Wound Infections
Do not operate with FUO or elevated WBC
Prophylactic antibiotics (eg. Cefazolin,
Levaquin)
Avoid skin shaving (clip if necessary)
Scrupulous skin prep
Meticulous sterile technique
Approximation of skin edges
Avoidance of crushing skin edges
Minimal electrocautery use but effective
hemostasis
Smallest sturdy caliber of suture
170. More avoidance of infection
Monofilament sutures
Antibiotic timed one hour before beginning
of procedure
Sufficiently snug closure to avoid
hematoma or seroma formation
Use currently recommended prophylaxis
from infectious disease in your hospital
Use tight control of blood sugar in
diabetics pre, intra, and post op x 1 week
171. the usual suspect
Some Hospitals Have A MRSA Rate Approaching 90% of
All Staph Infections: Try Avoiding Implants In These
Hospitals
174. Treatment of Infection
Sterile Q tip exploration of open
wound...if subcutaneous layer is intact,
pack wound with sterile gauze and
change 2x daily
If subcutaneous layer is open, then I and
D in the OR with a pulsation irrigation
system with bacitracin 50,000U per liter
saline
Culture at time of probing
Appropriate antibiotic therapy
Explant if pocket infected or deep spinal
wound infection
175. If the pump pocket is infected, explant.
Cultures preop via pocket aspiration or
intraoperative gram stain
177. Avoidance of Post Op Bleeding
Preoperatively stop anticoagulants 72-
96 hours, NSAIDs 3-4 days; ASA, Plavix,
Ticlid, garlic, ginsing, vit E- 10 days;
ginko 24 hours
Dry field before closing
Use layered interrupted suture closure
including skin
Approximation of skin edges
with mattress stitch
178. Treatment Post Op Bleeding
Pressure dressing
Reassurance
More frequent monitoring for the terrible
tetrad of hematoma, infection, necrosis,
dehiscence
May require evacuation if continued
expansion occurs
179. “Nurse Wright, when I givethe signal, you slap
that Band-Aid on him as fast as possible”
182. Post Dural Puncture Headache
Loss of CSF at time of implant or from
persistent CSF leak
Positional headache with or without
abducens nerve traction symptoms
Incidence approx 15% severe
Immitrex is a good first choice
Consider blood patch but only if
absolutely necessary: consider adjacent space
entry
183. Persistent Leaks: Spinal-Cutaneous
CSF Leak
Continued CSF
Drainage from
Wound
More Common
After Old Spinal
Catheter Removal
Options: Time or
Epidural Blood
Patch
Do Not Probe
Wound
Lying Supine May
Help Slow Leak
184. CSF Hygroma
Persistent CSF leak into subcutaneous
tissues causing a subcutaneous
collection
May be confused with seroma
Incidence 0.5% with purse-string suture
(Naumann), 0.5%-8% without
May persist 4 weeks
Treatment: compression dressing, tap
only if concerned about infection
Caudal catheter blood patch may be
helpful
185. Early Fascial Stitch Rupture Caused Frequent Pump Rotation
With Subsequent Torque At Connection and CSF Hygroma
187. IT Drug Overdose
Whereas there are only 4 reported cases of post
intrathecal injection seizures after morphine,
there are many cases of improper drug dosing
resulting in early somnolence, respiratory
depression, and death
These may occur in the PACU
Do not ever permit a nurse or tech to access the
bolus port without your immediate presence and
direction…nurses should absolutely never ever
inject contrast into the bolus port, however
there are some currently doing this.
Check the programming personally to make sure
there is no overdose when giving an initial bolus.
188. Long Term Side Effects Are Possible
from Intrathecal Infusion Therapy
189. III. Late Complications
Pump Malfunction (battery depletion, clogged
internal filter, gear 5 dysfunction, MRI exposure >
1.5 Tesla, leaky access port, mis-programmed)
Pump migration (flipped pump or pump migration
due to increased or decreased weight )
Epidural abscess
Catheter disconnect or kinking
Catheter penetration (from needles or surgery)
Catheter migration (from intrathecal CSF)
Spinal granuloma formation
Seeded infection
190. Sudden Onset Generalized Severe
Pain and Withdrawal Symptoms
If Recent Refill, check invoice on drug
Query program to insure is correct
Simultaneous Check of Reservoir Volume
and Pump Myelogram or Indium Scan
If catheter system is intact, then do a rotor
study if Indium reservoir scan above not
performed (takes 3 days) or in a non-
programmable pump perform serial residual
volume checks.
Proper Medication is Not Reaching Spinal Receptors
195. New Severe Low Back or Mid
Back Pain with Myelopathy
MRI lumbar spine to rule out epidural
abscess, new lumbar disc problem or
spondylolisthesis, arachnoiditis, spinal cord
infarction, and granuloma of the spine
C-reactive protein, ESR, and CBC useful
196.
197. Epidural abscess
L4-5 with disciitis
Epidural Abscess:
-Intense back pain midline
-Slight or normal elevation
of WBC
-Elevated C reactive protein
-MRI diagnosis
198. Inflammatory Mass (Granuloma)
• Associated with high
concentration or high dose
intrathecal opioid
Presentation: loss of
analgesia, new pain +/-
neurological deficits
Has not been described in
patients receiving baclofen
alone
201. Inflammatory Mass
Recommendations for the diagnosis, treatment, and prevention of
catheter-tip granuloma formation
Diagnosis
1. Document a thorough baseline evaluation.
2. Document three-dimensional location of the intrathecal catheter
tip at implantation.
3. Provide attentive follow-up and remain alert to diminishing
analgesic effects, loss of previously satisfactory pain relief,
remarkable or unusual increases in the patients underlying pain,
steep or frequent dose escalations, or neurologic symptoms
suggestive of an inflammatory mass.
4. Have a low threshold of performing contrast-enhanced T1-
weighted MRI or CT-myelography.
Treatment
1. Mildly symptomatic patients can be treated conservatively by
drug cessation through the catheter into the mass.
2. Patients with severe neurologic symptoms should have a
neurosurgical consult and possible neurosurgical removal of the
mass. Hassenbusch S et al: Management of Intrathecal Catheter-Tip Inflammatory Masses: A
Consensus Statement. Pain Medicine 2002;3(4):315-323
202. Inflammatory 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
203. Catheter Granulomas in
Patients
Neurosurgery. 2002 Jan;50(1):78-86;
discussion 86-7. Inflammatory mass
lesions associated with intrathecal drug
infusion catheters: report and
observations on 41 patients. Coffey RJ,
Burchiel K
30 of the 41 underwent surgery for
cauda equina syndrome, 11 of these
were non ambulatory afterwards
Only seen with narcotic infusion
204. Chronic IT MS Infusions
Produce Dose Related
Significant Side Effects in
Sheep
MS IT sheep infusions 12-18mg/day produce
inflammatory masses extending the length of
the catheter and hindlimb deficits in 2/3 of
sheep. 6-9mg/day produced 5cm inflammatory
mass; 3mg/day produced no inflammation.
Anesthesiology. 2003 Jul;99(1):188-198. Safety of
Chronic Intrathecal Morphine Infusion in a Sheep Model.
Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,
Johansen MJ, Hassenbusch SJ.
205. IT MS Produces Motor Deficits and
Inflammatory Masses on the Spinal
Cord 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.
206. 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
207. Arachnoiditis
A permanently painful condition that may
include loss of bowel or bladder control,
systemic effects, and motor dysfunction
More common after spine trauma, spine
surgery, and contrasts.
Is rare in the US and is seen only on a
small fraction of MRIs
208. 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
213. Operative Photograph: Final stage of adhesive
arachnoiditis. Appears to be an empty cavity,
nerves totally encased in dense scar tissue
214. Increasing Residual Volumes
and Decreasing Pain Control
Internal filter occluded (eg. Meperidine at
100mg/cc or MS at 50-100mg/cc)
Battery Failure (Programmable Pumps)
Internal programmable pump malfunction
Catheter occlusion (kinking)
?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.
216. Expected Residual Volume
with Increasing Pain
Catheter disconnect or migration
Tolerance to the drug
New or worsening disease (eg.
metastasis)
With low residual volumes, infusion rate
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.
218. Inability to Access Pump
Inexperience of person performing refill
Pump inversion
Pump rotation in skin fold (obesity)
Seroma, 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.
222. Lower than Expected
Residual Volume
Pump overfill on last refill
Partial refill: needle pulled out before refill
complete
Malprogrammed pump
Primary pump malfunction
Septum leakage
Surreptitious patient access of pump (Anesthesiology. 2004
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
223. Inability to Fill Reservoir
Initially or During Refill Period
Reservoir valve dysfunction or activation
Technical problem with needle
placement in septum
Air injected into reservoir
Lack of removal of prior residual fluid or
attempted 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
224. Headache, nausea, vomiting
If hygroma or edema along catheter is visible,
consider CSF leak due to catheter migration or
pericatheter leakage from dura (positional
headache)
If there is fever and rigid neck, suspect
meningitis
If none of the above, check pump
programming and 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.
226. IV. Medication Effects
Tolerance
Loss of libido
Peripheral edema
Rash/hives
Nausea/vomiting
Sedation
Weight gain
Drug precipitation
Urinary retention
Constipation
Diaphoresis
GRANULOMA
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
227. Tolerance is the
Norm
Mean MS dosing increased from 1.2mg to
5.1mg after 24 months J Pain Symptom Manage.
2001 Oct;22(4):862-71. Long-term intrathecal infusion of
drug combinations for chronic back and leg pain.
Mean MS dosing increased from 1.1 mg to
3.1mg after 6 months Surg Neurol. 2001
Feb;55(2):79-86; discussion 86-8. Continuous intrathecal
morphine treatment for chronic pain of nonmalignant
etiology: long-term benefits and efficacy. Kumar K, Kelly
M, Pirlot T.
228. Tolerance
The average increase in the amount of
narcotic used from month 1 to month
12 is a factor of 2.5 times.
Adding adjunctive meds may lessen this
Appears to be mediated by the NMDA
receptor activation by narcotics
No evidence drug holiday or opiate
rotation makes any difference
May consider oral magnesium and
NMDA antagonists, CCK agents,
microdose naltrexone orally
229. Hypogonadism in Males with
Intrathecal 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
230. Hypogonadism in
Postmenopausal Females with
IT 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
231. Percent of Patients with
Significant Reduction or
Absence 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
232. Diagnostic Recommendations
for Sexually Active Patients
Baseline FSH, LH in women and baseline
testosterone, LH in men prior to implant
One month post implant testing
Endocrinology referral when appropriate
(especially for women)
233. Treatment Options:
Androderm for males if the PSA is normal
and there is no history of prostate CA.
Injectable testosterone if above is not
possible
Viagra or equivalent for both males and
females if not contraindicated by other
medical conditions
Consider urology consultation
234.
235. Peripheral Edema
Much higher incidence in patients with pre-
existing arterial or venous vascular disease,
DVT history, and is made much worse in
patients who already have peripheral edema
6-20% incidence with IT opiate infusions
8/37 patients receiving hydromorphone IT
exhibited peripheral edema (Anderson et al)
Only 16% improve through opiate rotation
Mechanism: release of vasopressin from
posterior pituitary (induced by IT opiates)
236. Treatment of Peripheral Edema
Induced by Intrathecal Opiates
Diuretics
Elastic support stockings
Compression pumps
Opiate rotation(unproven)
Discontinuation of opiates (In a small
study of 23 patients, the reduction of
intrathecal opiates improved peripheral
edema)
Leg edema from intrathecal opiate infusions. Eur J Pain. 2000;4(4):361-5.
237. Rash/hives
Rare with intrathecal infusion since the
non-immunological production of hives
is due to mast cell degranulation due to
a direct morphine effect. However, in
the CSF there are not many mast cells.
Rashes may be due to pruritic patient
response.
Rash may be due to herpes reactivation
Treatment is switching to an alternative
opiate.
238. Nausea/vomiting from Intrathecal
Opiates
Direct effect of hydrophilic opiates on the
vomiting center and CTZ.
Usually is self limiting
50% have nausea/vomiting
immediately after
implantation: this drops to
25% after 1 year
Incorporate conservative
treatments-cyclizine may
be more effective than some
other therapies
239.
240. Sedation
Too high a drug dose
Combination effect with other sedatives
May be due to pump mis-programming
Treatment: Switch to a more lipophilic drug (fentanyl,
sufentanil) or reduce rate of infusion; add Provigil
200mg PO BID-TID, dexadrin, Vivactyl
241. Weight Gain
Through reduction in
GH, muscle is loss and
fat is added.
Lack of activity due to chronic
pain
Peripheral edema
Failure to adjust eating
downward in spite of
decreased TSH and GH
244. Urinary Retention
Present in approx 42% initially but
gradually declines
May be detrusor muscle direct effect
Treatment: carbichol, flomax.
Catheterize if severe
245. Constipation
Up to 50% with IT MS infusions
1st step: increase water consumption
2nd step: OTC laxatives
3rd step: Miralax
4th step: Pyridostigmine
246. Paice JA, Penn RD,
Shott S: Intraspinal
morphine for chronic
pain: a retrospective,
multicenter study. J
Pain Symptom Manage
1996;11:71-80
Winkelmuller M,
Winkelmuller, W:
Long-term effects of
continuous intrathecal
opioid treatment in
chronic pain of
nonmalignant
etiology. J Neurosurg
1996;65:458-467
Winkelmull
er
Paice
4.9
5.4
11.7
7.2
13.3
25.2%
8.5
Diaphoresis
4.9
Reduced libido
Weight gain
6.1
Edema
14.6
Pruritus
42.7
Urinary retention
50
Constipation
36.6%N,
24.4V
Nausea and vomiting
247. Side Effects of Systemic vs.
Intrathecal Opioids
Adverse Events
Short-Term Long-Term
Side Effect Systemic Intrathecal Systemic Intrathecal
Constipation ++ (+) + -
Nausea ++ (+) (+) -
Vomiting + (+) (+) -
Pruritus (+) (+) - -
Urinary retention (+) (+) (+) -
Erectile dysfunction (+) (+) (+) (+)
Sedation + - - -
Respiratory - - - -
depression
Endocrinological - - + +
changes
++ = Side effect occurs in most patients + = Side effect occurs in some patients
(+) = Side effect occurs, but tolerance develops - = Side effect does not occur
Short- and Long-term Side Effects: Systemic vs. Intrathecal Opioids
Naumann, et al. Neuromodulation. 1999;2(2):92-107. (From Mueller-Schwefe
G.’s presentation at 4th International Congress of the International
Neuromodulation Society; September 20 1988; Lucerne, Switzerland)
248. Reduction in 15 Toxicities
*Statist.
Signific.
(P<0.05)
Individual
Toxicity
Reduction in Mean
Severity
CMM
IDDS
-0.3 -0.2 -0.1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8
Reduced libido
Urticaria
Pruritus
Weight loss
Vomiting
Nausea
Dehydration
Constipation
Anorexia
Personality
Memory loss
Reduced level of consciousness
Confusion
Fatigue
*
*
Impotence
Journal of Clinical Oncology, Vol 20, No 19, October 1, 2002: 4040-4049.
249. Oral Robinul
Diaphoresis
Surgical decompression/Catheter
revision, change to hydromorphone
Inflammatory mass
Mg, NMDA ant orally
Tolerance
Replace catheter/filter drug
Precipitation
Reduce morphine/add bupivacaine,
Androderm, Viagra
Loss of libido
Change medication
Weight gain
Change medication, diuretic
Leg Edema
Diphenhydramine, Zyrtec
Pruritus
Catheterization
Carbachol 2mg/Naloxone 0.2mg
Urinary retention
Laxative/Stool softener
Constipation
Anti-emetic, switch narcotic
Nausea and vomiting
250. In spite of pump system functioning
properly, patient is convinced the
pump is not doing anything...
Turn off pump or withdraw all the meds
from the reservoir (unless baclofen is
the primary drug)
Some have unrealistic expectations-
need help in redefining these
Some patients are just nuts.
If you don’t like the patient,
then don’t implant. Try to find out
if they are nuts beforehand.
251. Contraindications To IT Pump
Infection
Subcutaneous fat less than 2.5 cm
Inadequate body size
Allergy to morphine
Coagulopathy
Pregnancy
Inability to keep follow-up appointments
Patient is Nuts
Substance Abuse
253. Pain Med. 2004 Mar;5(1):6-13. Intrathecal drug delivery for treatment of chronic low
back pain: report from the National Outcomes Registry for Low Back Pain. Deer T,
Chapple I, Classen A, Javery K, Stoker V, Tonder L, Burchiel K. Center for Pain Relief,
Charleston, West Virginia 25301, USA. doctdeer@aol.com OBJECTIVE: To obtain data on
patient demographics, clinical practices, and long-term outcomes for patients with
chronic low back pain treated with implantable drug-delivery systems. DESIGN: The
National Outcomes Registry for Low Back Pain collected data at baseline, trialing,
implant (or decision not to implant), and at 6- and 12-month follow-ups. Data were
collected at all time points, regardless of implant status. OUTCOME MEASURES: Numeric
pain ratings and Oswestry Low Back Pain Disability scores from implanted patients were
compared among baseline and 6- and 12-month follow-ups. Patients were also asked to
rate their quality of life and satisfaction with the therapy. RESULTS: Thirty-six physicians
enrolled 166 patients to be trialed for drug-delivery systems. The trialing success rate
was 93% (154 patients). In all, 136 patients (82%) were implanted. In the implant
group, numeric pain ratings dropped by more than 47% for back pain and more than
31% for leg pain at the 12-month follow-up. More than 65% of implanted patients
reduced their Oswestry scores by at least one level at their 12-month follow-ups
compared with baseline. At 12-month follow-ups, 80% of implanted patients were
satisfied with their therapy and 87% said they would undergo the procedure again.
CONCLUSIONS: Current clinical practices related to trialing of drug-delivery systems
resulted in the majority of patients successfully trialed. At 12-month follow-ups,
implanted patients experienced reductions in numeric back and leg pain ratings,
improved Oswestry scores, and high satisfaction with the therapy. Copyright American
Academy of Pain Medicine
254. J Neurosurg. 2002 Oct;97(4):803-10. Treatment of chronic pain by using intrathecal
drug therapy compared with conventional pain therapies: a cost-effectiveness analysis.
Kumar K, Hunter G, Demeria DD. Department of Surgery, Section of Neurosurgery, Regina General
Hospital, University of Saskatchewan, Regina, Saskatchewan, Canada. kkumar@reginahealth.sk.ca
OBJECT: The object of this study was to compare the cost-effectiveness of intrathecal drug therapy
(IDT) with that of conventional pain therapy (CPT) in patients suffering from chronic low back pain
caused by failed back syndrome. In this study, the authors tabulated actual costs, in Canadian
dollars, in a consecutive series of patients undergoing IDT within the Canadian health care system
and have compared them with costs in a control group in the same environment. The influence of
these treatments on the quality of life (QOL) was also analyzed. METHODS: The authors report
on a series of 67 patients suffering from failed back syndrome, 23 of whom underwent
implantation of a programmable drug delivery pump and 44 of whom acted as controls.
Patients were followed for a 5-year period during which the investigators tabulated the
actual costs incurred for diagnostic imaging, professional fees, implantation costs
including hardware, nursing visits for maintenance of the pumps, alternative therapies,
and hospitalization costs for breakthrough pain. From this data, cumulative costs for
each group were calculated for a 5-year period. Patient responses on the Oswestry Pain
Questionnaire were analyzed to assess the impact of treatment on QOL. The actual
cumulative costs for IDT during a 5-year period were $29,410, as opposed to $38,000
for CPT. High initial costs of equipment required for IDT were recovered by 28 months.
After this time point, managing patients with CPT became the more expensive treatment
option for the remainder of the follow-up period. The Oswestry Disability Index showed
a 27% improvement for patients in the IDT group, compared with a 12% improvement
in the control group. CONCLUSIONS: In patients who respond to this treatment, IDT is
cost effective in the long term despite high initial costs of implantable devices.
255. Surg Neurol. 1998 Jan;49(1):92-8; discussion 98-9. Intrathecal morphine pump as a
treatment option in chronic pain of nonmalignant origin. Angel IF, Gould HJ Jr, Carey ME.
Department of Neurosurgery, Louisiana State University Medical Center, New Orleans
70112, USA. BACKGROUND: Implantable pumps for the delivery of intrathecal morphine
have become a common option for administering opiate medication for the management
of pain in patients with terminal cancer. Options for treating chronic pain of non-
malignant origin are more controversial. This study describes responses to intrathecal
morphine administration for managing chronic pain in patients without an underlying
malignancy. METHODS: Eleven patients between the ages of 29 and 81 years, nine with
failed back syndrome (FBS) and two with neuropathic pain (NP) from other causes, were
chosen from 15 consecutive individuals referred to neurosurgery clinic. The presenting
levels of pain and a functional-economic outcome level were determined for each
patient. Patients were admitted to the hospital for therapeutic trials and were assessed
for the appropriateness of their analgesic response and for adverse responses to the
medication. A morphine pump was implanted in five males and six females who were
followed for up to 3 years. RESULTS: A good to excellent analgesic response was seen in
8 (73%) patients (6 FBS; 2 NP). In the remaining three patients (27%), the analgesic
response was judged poor (3 FBS). In patients with FBS, the total effective response
was 67%. Two patients experienced bladder dysfunction requiring pump removal. Other
adverse effects of pump placement were rare. CONCLUSIONS: The morphine pump was
found to be a viable alternative in the management of failed back syndrome. Its use in
long-term therapy, however, is not without limitations and should be a last choice
option.
256. J Neurosci Nurs. 1998 Aug;30(4):233-9, 243-4. Managing chronic
nonmalignant pain with continuous intrathecal morphine. Valentino L, Pillay KV,
Walker J. Methodist Hospitals, Merrillville, Indiana 46410, USA. One alternative
to traditional treatment modalities for chronic pain is continuous intrathecal
administration of morphine via an implanted pump. However, relatively little is
known about the benefits and long-term complications of this therapy for
chronic nonmalignant pain. The purpose of this study was to describe patient
responses to continuous intrathecal morphine over the course of one year with
respect to morphine dosage used, complications and subjective assessments of
pain. Data were obtained from twelve patients who completed one year of
therapy. After one year, a 42% reduction in pain as measured by the McGill
pain questionnaire had occurred (p < .01). A similar 41% reduction in pain was
also present based on the Verbal Descriptor Scale (p < .01). A 35% reduction
in the perceived hardship of pain was present (p < .01) accompanied by
anecdotal comments that an improvement in the ability to manage activities of
daily living had occurred. One patient was able to return to work. A statistically
nonsignificant increase in the mean daily dosage of morphine occurred and
few long-term adverse effects were present. Complications of implantation
occurred in 33.3% of the patients and were successfully managed without
discontinuing therapy. In selected patients with chronic pain, intrathecal
administration of morphine via an implanted pump can reduce pain with
minimal long-term adverse effects or complications
257. Clin Ther. 1997 Jan-Feb;19(1):96-112; discussion 84-5. Cost-effectiveness of long-term
intrathecal morphine therapy for pain associated with failed back surgery syndrome. de
Lissovoy G, Brown RE, Halpern M, Hassenbusch SJ, Ross E. A decision analytic study
was conducted using computer simulation to project the outcomes in a simulated cohort
of patients whose treatment for back surgery had failed. The objective of this study was
to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an
implantable pump relative to alternative therapy (medical management) over a 60-
month course of treatment. IMT administered by way of an implantable pump can provide effective pain
relief for selected patients whose less invasive treatment modalities have failed. Previous research suggested that
a pump implant is less costly than alternative methods providing comparable analgesia for treatment exceeding
12 to 18 months. However, those analyses did not include the cost of complications or pump replacement.
Scenarios representing the course of IMT, devised by a panel of experts, were represented as treatment pathways
in a Monte Carlo simulation. Adverse event rates were drawn from published data supplemented by expert
judgment. Direct costs were based on a health insurer paid claims perspective (direct costs) discounted at a 5%
annual rate. The cost-effectiveness of IMT was calculated based on a report of 65% to
81% "good to excellent" pain relief relative to alternative (medical) management. With
both adverse event probabilities and costs set at most likely (base case) values, the
expected total cost of IMT over 60 months was $82,893 (an average of $1382 per
month). In a sensitivity analysis, the best case (low adverse event rate, low cost)
estimate was $53,468 ($891/mo), whereas the worst case (high adverse event rate,
high cost) estimate was $125,102 ($2085/mo). Cost-effectiveness estimates ranged
from $7212 (best case) to $12,276 (worst case) per year of pain relief. Results from a
computer simulation designed to collect the costs not included in previous empiric
research indicate that IMT appears to be cost-effective when compared with alternative
(medical) management for selected patients when the duration of therapy exceeds 12 to
22 months.
258. Rehabil Nurs. 2003 Sep-Oct;28(5):159-63. A self-report of quality of life of
patients receiving intrathecal baclofen therapy. Staal C, Arends A, Ho S. Center for Limb
Differences, Mary Free Bed Hospital and Rehabilitation Center, 235 Wealthy Street, Grand Rapids, MI 49503, USA.
cstaal@mfbrc.com The purpose of this study was to explore through a department quality
improvement tool a possible relation between quality of life (QOL), complication rates,
and length of intrathecal baclofen (IB) treatment as reported by patients receiving IB
therapy in a community-based rehabilitation center outpatient clinic. A second objective
was to examine complication rates among the clinic's patients. No conclusions could be drawn
as to the relation between QOL, various reported complications, and length of treatment. A rank order frequency
of areas reported by respondents to have the greatest impact on their QOL could be extrapolated from the data
collected. In addition, complication rates among the patients who responded to the survey could be reported.
Surveys from 49 patients about their experiences with IB therapy were analyzed.
Respondents included 30 adult and 19 pediatric patients. Thirty-six patients (73%) had
used the IB pump for 1 year or more. The survey included questions about QOL,
complications, and length of IB treatment. Forty-three respondents (88%) stated
they felt that their QOL had improved with IB therapy. Four patients (8%)
responded that they were not sure that it had, and only 2 patients (4%) said
that IB had not improved their QOL. The most frequently reported positive effects
on QOL were reported in the following areas: spasticity control without the sedative
effect of oral medication; ease of care for caregivers; easier positioning; less
pain/increased comfort; and improved patient transfers. High ratings of improvement in the
patients' QOL were reported despite a reported overall complication rate of 39%. The most common
complications cited were infection and catheter breakage or disconnect. The overall infection rate for respondents
was 10% (5 patients of the 49 surveyed reported infection). The rate of catheter breakage or disconnect was also
10%. Despite the complications reported, 46 patients stated they would recommend baclofen treatment to
others. Three patients did not respond to the question. None of the patients said they would not recommend
baclofen to others.
259. Impact of Intrathecal Morphine
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Great Moderate Slight
Effect on ADL
Patient Satisfaction
Paice JA, Penn RD, Shott S. Intraspinal Morphine for Chronic Pain: A Retrospective, Multicenter Study, JPSM,
Feb. 1996; 11(2):71-80.
260. Clinical Experience with
Intrathecal Therapy
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Patients Receiving
Good to Excellent
Pain Relief
Paice et al.,
1996 95%
97% Gilmer-Hill,
1999
88% Krames,
Gershow,
1985
84% Penn,
Paice, 1987
Follett et al., Z
1992 77%
64% Onofrio,
Yaksh, 1990
76% Devulder,
1996
79%
Shetter,
1986
261. Surg Neurol. 1999 Jan;51(1):6-11. Intrathecal morphine delivered via
subcutaneous pump for intractable pain in pancreatic cancer. Gilmer-Hill HS, Boggan
JE, Smith KA, Frey CF, Wagner FC Jr, Hein LJ. Department of Neurological Surgery, UC Davis Medical Center,
Sacramento, California 95817, USA. BACKGROUND: Pain secondary to unresectable pancreatic cancer is
frequently severe and extremely difficult to control with traditional methods of analgesia. This retrospective study
reports the analgesic effects of intrathecal morphine sulfate by implanted infusion pumps in nine patients with
unresectable adenocarcinoma of the pancreas. METHODS: Nine patients were implanted over a 2-
year period. Preoperative morphine i.v. equivalents were a mean of 81.51 mg/day, with
a range of 20-140 mg/day. Patients were hospitalized for a trial dose of 1-2 mg of
intrathecal Duramorph, 1 mg/ml, via lumbar puncture to assess whether adequate pain
relief could be achieved and whether there would be drug-related side effects.
RESULTS: All patients who received a trial dose experienced excellent pain relief, and
subsequently underwent implantation of a lumbar subarachnoid catheter and infusion
pump during the same hospitalization. The mean number of days from diagnosis to
pump implant was 119, with a range of 3-587 days. The mean maximum daily dose was
21.28 mg, with a range of 3-73.10 mg. No patient experienced respiratory depression or
excess sedation which prevented achievement of pain control. Minor supplemental
narcotic use was documented in three of the nine patients. Assessment of pain control
was made by the level of activity and the analog pain scale, with 0 being no pain and 10
being the worst pain imaginable. All of the patients experienced good to excellent relief
of pain. The mean duration of intrathecal morphine sulfate use until death was 137.3
days, with a range of 52-354 days. CONCLUSIONS: This series of nine patients indicates
that long-term administration of intrathecal morphine via implanted infusion pump in
patients with pancreatic cancer is both efficacious and safe. All patients and their
families reported an improved quality of life with an increased level of activity.
262. Curr Pain Headache Rep. 2005 Aug;9(4):243-8. Pain management, including intrathecal
pumps. Smith TJ, Swainey C, Coyne PJ. Division of Hematology/Oncology and Palliative
Care, Massey Cancer Center of Virginia Commonwealth University, MCV Box 980230,
Richmond, VA 23298-0230, USA. tsmith@hsc.vcu.edu. Even when managed
according to guidelines, approximately 14% of cancer patients have unrelieved
pain or unacceptable side effects, and there is good evidence that patients still
are not receiving optimal therapy. Implantable drug delivery systems (IDDS)
administer small amounts of drugs directly to the spinal cord and reduce
systemic narcotic exposure by a factor of 300 to one. In a large randomized
trial of 202 patients with pain scores of 7.5 or higher, despite 200 mg or more
of morphine or equivalent narcotics, IDDS gave better clinical success than
comprehensive medical management (84.5% vs 70.8%, P=0.05). Pain scores
were reduced by 52% versus 39%, drug toxicity scores were reduced by 50%
versus 17%, and IDDS patients lived longer. Even the most refractory pain
patients--those failed by a month of comprehensive medical management by
experts--when subsequently provided with IDDS, had a 27% reduction in pain
scores and a 50% reduction in drug side effects. Given multiple
positive small cohort studies and a positive high-power
randomized trial, IDDS should be considered as the best
treatment for this population.
263. Palliat Med. 2004 Sep;18(6):507-15. Evolving spinal analgesia practice in
palliative care. Baker L, Lee M, Regnard C, Crack L, Callin S; Tyneside Spinals
Group. St. Oswald's Hospice, Newcastle upon Tyne, UK.
lisabaker@doctors.org.uk Intraspinal analgesia can be helpful in some patients
with intractable pain. Over 15 years palliative care professionals evolved their
spinals policy through a repeated series of evaluations, discussions and
literature reviews. One hundred intraspinal lines were then reviewed. Notable
changes in policy were the switch from epidurals to intrathecals, and the
insertion of lines during working hours rather than as emergencies. Our
efficacy, and frequency of adverse effects, is equal or better to published
studies. Key issues in reducing adverse effects were the improved care of the
spinal line exit site, a change from bolus administration to continuous
infusions, and modifying line insertion techniques. Current policy is to use
continuous infusions of diamorphine and bupivacaine in a 1:5 ratio through
externalized intrathecal lines. The lines are effective in approximately
two thirds of patients and can be kept in place for up to 18 months.
The policy continues to be updated and common documentation is now in
place.
External Intrathecal Lines for Long Term Use: Argument for Functional Intrathecal Trials
264. High Dose Oral Opiate Side Effect
Reason Number 228
to Implant an
Intrathecal Pump
Editor's Notes
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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.