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CTRI Number  CTRI/2024/08/072083 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain control in patients undergoing laparoscopic cholecystectomy with abdominal muscle nerve block and low pressure of abdomen during surgery  
Scientific Title of Study   A pilot study comparing pain relief after laparoscopic cholecystectomy in standard pressure pneumoperitoneum with port site infiltration versus low pressure pneumoperitoneum with laparoscopically guided transversus abdominis plane block and standard pressure pneumoperitoneum with laparoscopically guided transversus abdominis plane block- A randomized control 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  Anita Dhar  
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi
Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi
New Delhi
DELHI
110049
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anita Dhar  
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi
Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi

DELHI
110049
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anita Dhar  
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi
Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi

DELHI
110049
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Source of Monetary or Material Support  
Room no 430, Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi, 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Room no 430, Department of Surgical Disciplines, AIIMS, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
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 Anita Dhar  AIIMS New Delhi  Room no 430,Dept. of Surgical Disciplines AIIMS New Delhi, 110029
New Delhi
DELHI 		 9810198239

dranitadharbhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard laparoscopic choecystectomy with port site infiltration  Standard laparoscopic choecystectomy with port site infiltration 
Intervention  Transversus abdominis plane block laparoscopically and low pressure pneumoperitonium   Laparoscopic guided transversus abdominis plane block with. [L-TAP]with Rupavacaine at premarked surface marked sites in laparoscopic cholecystectomy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) All patients undergoing laparoscopic cholecystectomy for chronic cholelithiasis.
2) BMI≤35
3) Above 18 years of age.
4) Able to provide informed written consent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
postoperative pain score among all the three study groups involved   at baseline immediate post operative period, 6 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To calculate the dose and requirement of rescue analgesia in the post operative period.
2. To find the incidence of nausea and vomiting among all the study groups.
3. To compare surgeon’s satisfaction on exposure and instrument manoeuvrability during surgery.
 		 6 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/09/2024 
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="0"
Months="6"
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 - NO
Brief Summary   Surgery for gall stone disease has been evolved from open surgery, which used to have a big surgical scar, associated pain and now to a laparoscopic technique which is currently considered as the gold standard. Laparoscopic procedure with small incisions and is comparatively, but not totally pain free. We want to evaluate if the combined benefit of low pressure pneumoperitoneum with laparoscopic guided transverse abdominis plane block in making the surgery as pain free as possible as compared to the standard pressure used now. 
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