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CTRI Number  CTRI/2024/05/067781 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 19/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of external oblique intercostal fascial plane block with local anesthetic infiltration for pain relief after laparoscopic cholecystectomy in obese patients 
Scientific Title of Study   Comparison of ultrasound guided external oblique intercostal fascial plane block with port site local anesthetic infiltration for postoperative analgesia after laparoscopic cholecystectomy in obese patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha P V 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room No. 413, BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, New Delhi, 110002. Central DELHI 110002 India

New Delhi
DELHI
110002
India 
Phone  8553166505  
Fax    
Email  dishapv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahil Singh 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Room No. 413, BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, New Delhi, 110002. Central DELHI 110002 India

New Delhi
DELHI
110002
India 
Phone  9810719025  
Fax    
Email  drrahilsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Disha P V 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room No. 413, BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, New Delhi, 110002. Central DELHI 110002 India

New Delhi
DELHI
110002
India 
Phone  8553166505  
Fax    
Email  dishapv@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002. 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, New Delhi,110002 
Type of Sponsor  Government medical college 
 
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 Disha P V  Lok Nayak Hospital  Operation Theatre Block, OT 1, 1st floor, Lok Nayak Hospital, JLN Marg, New Delhi-110002 Central DELHI
New Delhi
DELHI 		 8553166505

dishapv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External oblique intercostal fascial plane block  Patients in this group will receive 20 ml of 0.25% bupivacaine into the external oblique intercostal plane on both sides using ultrasound guidance (Total duration of intervention : 1 year) 
Comparator Agent  Port site local anesthetic infiltration  In this group, the four port sites will be infiltrated with 20 ml of 0.25% bupivacaine for postoperative analgesia (5ml in each port) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients belonging to age group 18-65 years fulfilling American society of anesthesiologists(ASA) physical status I, II, III criteria
2. Patients with BMI: 25-40 kg/m2 
 
ExclusionCriteria 
Details  1. Contraindications to nerve block like coagulopathies and local site pathology
2. Pregnant patients
3. Any allergy to study medications
4. Chronic opioid use
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total consumption of rescue analgesics at 24 hours postoperatively  24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to request for first rescue analgesia
2. NRS at 2,4,6,12 and 24 hours after surgery at rest and at movement
3. Quality of recovery at 24 hours post operatively
4. Postoperative sedation score
 		 12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 (Others) - 

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 05-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   We are comparing the efficacy of external oblique intercostal fascial plane block with post site local anesthetic infiltration for post operative analgesia in obese patients between ages 18 to 65 years and BMI between 25 to 40 kg/m2 undergoing laparoscopic cholecystectomy, taking a total sample size of 60, 30 patients in each group. 
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