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CTRI Number  CTRI/2024/02/063345 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   A RANDOMISED CLINICAL TRIAL 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Opioid free Anaesthesia for laparoscopic cholecystectomy surgeries - A Randomized clinical trial. 
Scientific Title of Study   Opioid free versus Opioid based Anaesthesia for laparoscopic Cholecystectomy- A Randomized clinical trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thaskin 
Designation  MD Anaesthesia postgraduate 
Affiliation  SHRI B.M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  Postgraduate Anesthesia. New girls PG hostel. Smt. Bangaramma sajjan campus, B.M. Patil Road. Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  7034467286  
Fax    
Email  thaskin.majeed@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavaraj Patil MD 
Designation  Associate Professor 
Affiliation  SHRI B.M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  Associate Professor. Department of Anaesthesiology, BLDE (Deemed to be University),Shri B.M.Patil Medical college and Research Center.Vijayapura,Karnataka.

Bijapur
KARNATAKA
586103
India 
Phone  7829655342  
Fax    
Email  drbnp2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Thaskin 
Designation  MD Anaesthesia postgraduate 
Affiliation  SHRI B.M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  Postgraduate Anesthesia. New girls PG hostel. Smt. Bangaramma sajjan campus, B.M. Patil Road. Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  7034467286  
Fax    
Email  thaskin.majeed@gmail.com  
 
Source of Monetary or Material Support  
Shri B.M. Patil Medical College,Hospital and Research Centre, Vijayapura Karnataka. 
 
Primary Sponsor  
Name  Dr Basavaraj Patil MD 
Address  Associate Professor. Department of Anaesthesiology, BLDE (Deemed to be University),Shri B.M.Patil Medical college and Research Center.Vijayapura,Karnataka 
Type of Sponsor  Other [Guide] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Thaskin  Shri B.M Patil Medical College Hospital and Research Centre.  Department of Anaesthesiology, BLDE (Deemed to be University), Vijayapura, Karnataka, Shri B.M Patil Medical College Hospital.
Bijapur
KARNATAKA 		 7034467286

thaskin.majeed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE (deemed to be university), SHRI B.M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Opioid group  Patients will undergo Laparoscopic cholecystectomy under conventional opioid based Anaesthesia 
Intervention  Opioid free Anaesthesia group  Patients will receive Anaesthestic doses of Lidocaine, Magnesium and Paracetamol in combination with preincisional infiltration and Intra peritoneal 0.25% Bupivacaine Instillations during Laparoscopic Cholecystectomy. study duration will be 1.5 years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients aged between 18-70 years.
Patients of either sex.
Patients admitted for laparoscopic cholecystectomy under General Anesthesia
with ASA Grade I & II 
 
ExclusionCriteria 
Details  Patients with Obstructive sleep Apnea Syndrome (OSAS),s having significant Cardiopulmonary, hepatic or renal insufficiencies,Allergy to Study medications.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain scores using Visual analogue scale (VAS) between
opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2,
4,6,12 and 24 hours. 		 Postoperative pain scores using Visual analogue scale (VAS) between
opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2,
4,6,12 and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare intraoperative Hemodynamic parameters like Heart rate, Systolic,
Diastolic Blood pressures and Mean Arterial pressures.
2. Duration of Post operative Analgesia
3. Total Analgesics consumed in the first 24 hours postoperatively 		 24 hours post operative observation. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) 30/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [thaskin.majeed@gmail.com].

  6. For how long will this data be available start date provided 31-01-2024 and end date provided 07-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 A study on Opioid free versus conventional opioid based Laparoscopic cholecystectomy. Aimed at comparing the  pain scores using VAS scores in both the groups along with  intraoperative Hemodynamics like heart rate, blood pressure, MAP. Also to compare the duration of analgesia post operatively, and total analgesics that will be consumed  in first 24 hours post operatively. Any associated adverse effects are also studied. Patients were divided by computer generated  random numbers into 2 groups of 34 patients each who are posted for elective laparoscopic cholecystectomy. Inclusion and exclusion criteria was evaluated and then informed consent was taken. The above study was held at Shri B.M Patil medical college and research centre , vijayapura, karnataka. At the end of the study, it was found that the Opioid free anesthesia group exhibited a significantly longer duration of analgesia compared to conventional opioid group. VAS scores were high in the opioid group especially in the first four hours postoperatively. Consumption of analgesics were less in Opioid free group when compared to conventional opioid group. Intraoperative systolic blood pressure was high in the OFA group, however it was clinically insignificant. Postoperative adverse effects were more prevalent in opioid group. 
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