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CTRI Number  CTRI/2025/11/097414 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   newer initiatives in gall bladder surgery 
Scientific Title of Study   Analyzing and comparing the efficacy of Ultrasound guided sub costal TAP Block and Modified BRILM block in blunting the hemodynamic response to port insertion and pnemoperitoneum in laparoscopic cholecystectomies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manisha Gupta 
Designation  Assistant Professor 
Affiliation  Jaipur National University 
Address  Deptt of Anesthesiology JNU Hospital Jagatpura Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9810371436  
Fax    
Email  drmanishagupta49@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manisha Gupta 
Designation  Assistant Professor 
Affiliation  Jaipur National University 
Address  Deptt of Anesthesiology JNU Hospital Jagatpura Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9810371436  
Fax    
Email  drmanishagupta49@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manisha Gupta 
Designation  Assistant Professor 
Affiliation  Jaipur National University 
Address  Deptt of Anesthesiology JNU Hospital Jagatpura Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone  9810371436  
Fax    
Email  drmanishagupta49@gmail.com  
 
Source of Monetary or Material Support  
Jaipur national University Institute for medical sciences and research centre, Jaipur 
 
Primary Sponsor  
Name  Jaipur National University 
Address  Jagatpura, Jaipur Rajasthan 302017 
Type of Sponsor  Private 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 Manisha Gupta  JNU Hospital  Room No. 5, Deptt of Anesthesiology,
Jaipur
RAJASTHAN 		 09810371436

drmanishagupta49@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Ultrasound guided nerve block  Ultrasound guided BRILMA block 
Intervention  Ultrasound guided nerve block  Ultrasound guided sub coastal TAP block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA Grade 1,2,3 patients posted for elective laparoscopic cholecystectomies 
 
ExclusionCriteria 
Details  Emergency surgeries
Allergic to local anaesthetics
Refusal to participate
Patients with skin disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic response to port insertion and pneumo peritoneum in laparoscopic surgery   Vitals monitoring every 5 minutes for 30 minutes post block.
 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative analgesia (pain score).
Duration of rescue analgesia  		 For 24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/01/2026 
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 - 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 - Informed Consent Form
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmanishagupta49@gmail.com].

  6. For how long will this data be available start date provided 13-11-2026 and end date provided 13-10-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Going hand in hand with the advancements in surgery, anaesthesia needs to be updated accordingly.

With advent of laparoscopic surgeries, issues like response to port insertion & pneumo-peritoneum need to be addressed
to provide quality care.

So, in laparoscopic cholecystectomy, apart from conventional GA, we have to block nerves (by subcoastal TAP / modified
BRILMA block) that innervate parietal peritoneum and
anterior abdominal wall muscles.

Real time imaging under USG guidance is a boon in performing these blocks.
 
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