1. A RANDOMIZED COMPARITIVE STUDY SHOWING THE
EFFECT OF OPIOID FREE ANALGESIA VS TRADITIONAL
MULTIDRUG ANALGESIA IN PERIOPERATIVE PERIODS OF
PATIENTS POSTED FOR ELECTIVE LAPAROSCOPIC
CHOLECYSTECTOMY
Name of Supervisor:
Dr. Vivek Mittal
Professor & Head of department
Name of Co-supervisors
Dr. Sushil Mittal
Professor & Head of department
Dr. Amandeep Kaur
Associate professor
2. Introduction
• Laparoscopic cholecystectomy is an effective surgical technique for the treatment
of cholecystitis with laparoscope show some benefits compare to open surgery.
• Some related post-operative complains such as abdominal incision pain, nausea
and vomiting, or other complaint are still challenging issues. Opioids are the most
potent and effective drugs to eliminate such procedure related pain.
• Side effects can result in prolonged hospitalization, increased treatment costs,
prolonged return to daily activities and effects the quality of post-operative
recovery for post-surgical patients.
• opioid free anesthesia (OFA) can control postoperative pain effectively, decrease
the incidence of long-term chronic pain, reduce opioids drug consumption, speed
up postoperative recovery, relieved patient anxiety and shorter the length of
hospital stay.
3. Aim and Objective
• Aim: A Randomized comparitive study showing the effect of opioids free
analgesia vs. traditional multidrug analgesia in perioperative period of patients
posted for elective laparoscopic cholecystectomy
• Primary objective To find out whether opioids free analgesia is better than the
Traditional multidrug analgesia approach for patients undergoing laparoscopic
cholecystectomy or not.
• Secondary objective: To assess and compare the level of anxiety, hemodynamic
stability, analgesia in both the approaches.
4. Material and Method
• Group X (Traditional multidrug analgesia)
Preoperative Counselling
After being posted for elective laparoscopic cholecystectomy, multi
aspect counselling of the patient and relatives will be performed, by
showing videos of the planned surgical procedure and anesthesia
technique on tablet. Education and psychological preparation of
patient, reduces anxiety and fear, improves overall patient satisfaction.
Special focus will be laid on relieving the anxiety and apprehension of
the patient and relatives.
5. • During preanaesthetic checkup- Patient preanaesthetic checkup will
be done in detail by taking all aspects in concern.
(1) Detailed history
(2) General/ Systemic/ local examination
(3) Standard investigation and advanced investigation if needed
(4) Complete airway examination/ Risk assessment/ ASA grading
7. • Day before Surgery-
Anxiolytic drugs (tab alprazolam 0.25mg)
• On Day of Surgery
(1) Anxiolytic drugs (tab alprazolam 0.25mg)
(2) Antacid drug (tab pantoprazole 40 mg P/O)
8. • Preoperative period-
(1) Premedication done 15 min before the patient shifted to
Operation Theater.
(2) Balanced salt solution @ 2 ml/kg/hour
(3) Injection glycopyrrolate 0.005- 0.01 mg/kg
(4) Injection midazolam 0.02-0.03 mg/kg
(5) Injection butorphanol 1 mg IV given
9. • Intraoperative period-
Induction with intravenous propofol (1-2mg/kg) and intubated using
appropriate size endotracheal tube after neuromuscular blockade with
injection vecuronium (0.1 mg/kg). Maintenance on Isoflurane with
oxygen and nitrous oxide and give muscle relaxant as needed all
hemodynamics parameters will be noted (BP, HR, RR, SPO2, ETCO2,
TEMP) 0min, 1min after surgical incision, 15min, 30min, 45min , 60min,
75min , 90min, 120min
10. After 1 hour surgery injection fentanyl 1mcq/kg will be given in 100
ml NS and Intravenous fluids will be give according to holiday Segar
method and patient will be extubated by giving injection glycopyrolate
(0.01mg/kg) and neostigmine (0.05mg/kg) and check the
hemodynamic parameter, time taken to awakening of patient will be
noted. While at the time of shifting injection fentanyl 50mcq will be
given in 100ml NS.
11. Postoperative period-
(1) Postoperatively fluid will be given @ 1.5 ml/kg/hour till patient nil
per oral which is around 6 hour.
(2) Injection tramadol 50mg will be given for analgesia, and as per
required.
(3) After 6 hour Tablet ultracet will be given as per requirement,
Hemodynamic monitoring, Time of recovery side effect such as nausea,
vomiting etc. and side effects are noted till discharge.
12. Group-Y (Opioids Free Analgesia)
• Preoperative counselling
After being posted for elective laparoscopic cholecystectomy, multi
aspect counselling of the patient and relatives will be performed, by
showing videos of the planned surgical procedure and anesthesia
technique on tablet. Education and psychological preparation of
patient, reduces anxiety and fear, improves overall patient satisfaction.
Special focus will be laid on relieving the anxiety and apprehension of
the patient and relatives.
13. • During preanaesthetic checkup-Patients preanesthetic checkup will
be done in detail by taking all aspects in concern.
(1) Detailed history
(2) General/ Systemic/ local examination
(3) Standard investigation and advanced investigation if needed
(4) Complete airway examination/ Risk assessment/ ASA grading
15. • Day before Surgery-
Anxiolytic drugs (tab alprazolam 0.25mg)
• On Day of Surgery-
(1) Anxiolytic drugs (tab alprazolam 0.25mg)
(2) Antacid drug (tab pantoprazole 40 mg P/O)
16. • Preoperative period
(1) Premedication done 15 min before the patient shifted to
Operation Theater
(2) Balanced salt solution @ 2 ml/kg/hour
(3) Injection glycopyrrolate 0.005- 0.1 mg/kg
(4) Injection midazolam 0.02-0.03 mg/kg
(5) Injection dexmedetomidine 1ug/kg IV given.
17. • Intraoperative period-
Induction with intravenous propofol (1-2mg/kg) and intubated using
appropriate size endotracheal tube after neuromuscular blockade with
injection vecuronium (0.1 mg/kg). Maintenance on Isoflurane with
oxygen and nitrous oxide and give muscle relaxant as needed.
Prevention of hypothermia will be done by using body warmer and
warm intravenous fluids and all Hemodynamics parameters monitors
(BP, PR, RR, SPO2, TEMPERATURE, ETCO2) in 0min, 1min after surgical
incision, 15min, 30min, 45min, 60min, 75min, 90min, 120min.
18. After 1 hour of surgery injection paracetamol 15 mg/kg iv given.
Injection ondansetron 4mg IV will be given to prevent post-operative
nausea and vomiting. After completion of the surgery neuromuscular
blockade will be reversed with injection neostigmine (0.05 mg/kg) and
injection glycopyrrolate (0.01mg/kg), extubating will be performed
when patient is fully awake. While at the time of shifting injection
paracetamol 500mg IV given in 100 ml NS
19. • Postoperative period- Postoperatively fluid will be given @ 1.5
ml/kg/hour till patient nil per oral which is around 6 hour Patient
(1) Opioid free analgesia (injection paracetamol 500mg IV first 6
hour or Then we assess the VAS Score if VAS>3 injection diclofenac 75
mg IV given.
(2) After 6 hour we give oral Tablet Paracetamol 500 mg orally.
(3) After 1-2 hour we will assess the VAS Score if still VAS >3, than
Tablet Zerodol-plus (Acelofenac+Paracetamol) will be given as per
requirement.
(4) Injection ondansetron 4 mg IV every 6 hourly to prevent PONV
20. (4) Injection ondansetron 4 mg IV every 6 hourly to prevent PONV
(5) Early removal of catheter
(6) Early oral nutrition
(7) Early mobilization
21. (8) Using numerical rating scale (0-10) note patient pain and anxiety
levels.
(9) After that allowed the patient to recover by their own.
Hemodynamic parameters monitors, Time of recovery side effect such
as nausea, vomiting etc. and side effects are noted till discharge.
22. REVIEW OF LITERATURE
• conghui hao et al (2023) conducted an randomized controlled study on
impact of opioid free-anesthesia on postoperative quality of recovery in
patient after laparoscopic cholecystectomy . They conducted study on 80
adult patient undergoing laparoscopic cholecystectomy alterated to an OFA
(opioids free anesthesia) or an opioids based anesthesia group and conducted
that the quality of recovery of patients receiving OFA was superior to those
reviving opioid anesthesia.
• charity taylor et al (2023) to determine the OFA and MULTIMODAL
ANALGESIA to see the outcome in patient undergoing spinal surgery. They
conducted that OFA patients had better patient outcome and reduced hospital
stay.
23. STUDY DESIGN
Study design : A systematic randomized study will be conducted in
department of Anaesthesiology & Critical Care
Study period : The probable duration of study will be one year after
approval from institutional ethics committee
Group 1 Traditional multidrug analgesia
Group 2 Opioid free analgesia
24. Inclusion criteria
1. Patient schedule to undergo elective laparoscopic cholecystectomy
2. Patient between 18 to 60 years of age group
3. Physical status of American Society of Anesthesiologist (ASA) grade I and II
4. BMI (15-30kg/m2)
5. Patient will Give consent
6. Patient have diabetic mellitus , hypertensive but controlled
25. Exclusion criteria-
1. Pregnant females
2. American Society of Anesthesiologist (ASA) grade III and IV
3. Emergency case
4. Children below 18 years old and adult >60 years old
5. Cardiac patients
6. Patient have diabetic mellitus / hypertensive but uncontrolled
7. Patient who will Not give consent
8. Patient on antiepileptic medication
9. Allergy to study drug
26. Statistical analysis
• Sample size calculation done on the basis of previous study-
• d = 0.6 (effect size)
• σ = 0.9(SD)
• Zβ = 1.28 (Area of standard normal variate at 90% power)
• Zα= 1.96 (at 95% confidence interval)
• Formula used- Sample size (n) = 2σ2 (Zβ+Zα)2
d2
2× (0.9)2 ×10.5 = 47.25
(0.6)2
After applying the formula sample size is 47.25 ≈ 48
• Considering 10% of non-response rate of 10%, the final sample size would
be 48 +5 = 53.
• So, 53 sample size will be taken in each group.
27. ETHICAL JUSTIFICATION
• The proposed study entitled “ A Randomized comparitive study showing the effect of opioids free
analgesia vs. traditional multidrug analgesia in perioperative periods of patients posted for elective
laparoscopic cholecystectomy ”.
• Informed written consent will be obtained from all the participants.
• All the drugs used in this study do not carry any harmful effects on the patients. Thus, the present
study is well within the ethical norms and is ethically justified.
28. प्रोटोकॉल / अध्ययन संख्या:
थीससस क
े सलए रोगी की पहचान संख्या:---------------------
पररयोजना का शीर्षक: एक यादृच्छिक तुलनात्मक अध्ययन जो ओसपओइड मुक्त एनाल्जेससया बनाम क
े प्रभाव को दशाषता है। वैकच्छिक
लैप्रोस्कोसपक कोलेससस्टेक्टोमी क
े सलए प्रस्तुत रोसगयों की पेररऑपरेसटव अवसि में पारंपररक मल्टीड
र ग एनाल्जेससया
अन्वेर्क का नाम: डॉ मनोज क
ु मार मोबाइल नंबर 9761990373
(संस्करण) प्रदान की गई सूचना पत्र की सामग्री को
मेरे द्वारा ध्यान से पढा गया है / मुझे सवस्तार से समझाया गया है, एक ऐसी भार्ा में सजसे मैं समझता हं,
और मैंने सामग्री को पूरी तरह से समझ सलया है। मैं पुसि करता हं सक मुझे प्रश्न पूछने का अवसर समला है।
अध्ययन की प्रक
ृ सत और उद्देश्य और इसक
े संभासवत जोच्छिम / लाभ और अध्ययन की अपेसित अवसि, और
अध्ययन क
े अन्य प्रासंसगक सववरणों क
े बारे में मुझे सवस्तार से बताया गया है। मैं समझता हं सक मेरी
भागीदारी स्वैच्छिक है और मैं सबना कोई कारण बताए सकसी भी समय अपनी सचसकत्सा देिभाल या कानूनी
असिकार को प्रभासवत सकए सबना वापस लेने क
े सलए स्वतंत्र हं। मैं समझता हं सक इस शोि में मेरी
भागीदारी से मेरे बारे में एकत्र की गई जानकारी और मेरे सकसी भी मेसडकल नोट क
े अनुभागों को सनयामक
प्रासिकरणों से या वहां से सजम्मेदार व्यच्छक्तयों द्वारा देिा जा सकता है जहां यह मेरे शोि में भाग लेने क
े सलए
प्रासंसगक है। मैं इन व्यच्छक्तयों को अपने ररकॉडष तक पहंचने, बैठकों और सम्मेलनों में उपच्छथथत होने और यसद
वांसछत हो तो प्रकाशन की अनुमसत देता हं। मैं उपरोक्त अध्ययन में भाग लेने क
े सलए सहमत हं।
सदनांक: थथान:
(हस्तािर/बाएं अंगूठे का सनशान)
प्रसतभागी का नाम: बेटा/बेटी/पत्नी:
पूरा डाक पता:
सूचित सहमचत
प्रपत्र
29. Consent Form
Protocol /Study number:
Patient identification number of thesis:
Title of project::A Randomized comparitive study showing the effect of opioids free analgesia vs. traditional multidrug analgesia in
perioperative period of patients posted for elective laparoscopic cholecystectomy
Name of investigator: Dr. Manoj Kumar Mobile No: 9761990373
The contents of the information sheet dated (version)……………. that was
Provided have been read carefully by me /explained in detail to me, in a language that I
comprehend, and I have fully understood the contents. I confirm that I have had the
opportunity to ask questions. The nature and purpose of the study and its potential risks /
benefits and expected duration of the study and other relevant details of study have been
explained to me in detail. I understand that my participation is voluntary and I’m free to
withdraw at any time, without giving my medical care or legal rights being affected. I
understand that the information collected about me from my participation in this research and
sections of any of my medical notes may be looked at by responsible individuals from Adesh
Medical College and Hospital or from regulatory authorities where it is relevant to my taking
part in the research. I give the permission for these individuals to have access to my records,
to present in meetings and conferences, and publications as desired I agree to take part in the
above study
Date: ……….. Place ……………. (Signature/left thumb impression) …………………………………….
Signature of investigator
Name of the participant
This is to certify that the above consent has been obtained in my presence.
