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CTRI Number  CTRI/2025/04/083792 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 31/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A clinical trial to study and compare the postoperative analgesic effects of two regional anaesthesia techniques, ultrasound guided modified BRILMA block and subcostal Transversus Abdominis Plane block in patients who are undergoing open cholecystectomy surgery under general anaesthesia. 
Scientific Title of Study   A Study Of the Postoperative analgesic effect between ultrasound guided modified BRILMA block versus subcostal Transversus Abdominis Plane Block in open cholecystectomy under general anesthesia. 
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. Manikandan Chidambaram 
Designation  Post Graduation Trainee 
Affiliation  R G Kar Medical College and Hospital 
Address  Dept.of Anaesthesiology and Critical Care Medicine, R.G. Kar Medical College, 1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal.

Kolkata
WEST BENGAL
700004
India 
Phone  7338762035  
Fax    
Email  maanikaandaan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Bani Parvati Magda Hembrom 
Designation  Associate Professor 
Affiliation  R G Kar Medical College and Hospital 
Address  Dept.of Anaesthesiology and Critical Care Medicine R.G. Kar Medical College, 1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal.

Kolkata
WEST BENGAL
700004
India 
Phone  9903207690  
Fax    
Email  banihembrom72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Bani Parvati Magda Hembrom 
Designation  Associate Professor 
Affiliation  R G Kar Medical College and Hospital 
Address  Dept.of Anaesthesiology and Critical Care Medicine R.G. Kar Medical College, 1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal.

Kolkata
WEST BENGAL
700004
India 
Phone  9903207690  
Fax    
Email  banihembrom72@gmail.com  
 
Source of Monetary or Material Support  
R.G.Kar Medical college and Hospital, 1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal, India. Pin- 700004. Only material support done. No financial support. 
 
Primary Sponsor  
Name  R G Kar Medical College and Hospital 
Address  1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal, India. Pin-700004 
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 Bani Parvati Magda Hembrom  R.G. Kar Medical College and Hospital, Kolkata.  Surgery Operation Theatre, Surgery Building, 1,Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal, India. Pin-700004
Kolkata
WEST BENGAL 
9903207690

banihembrom72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE, R G KAR MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A Study Of the Postoperative analgesic effect between ultrasound guided modified BRILMA block versus subcostal Transversus Abdominis Plane Block in open cholecystectomy under general anesthesia.  This interventional study will require a total duration of 6 months in surgery operation theatre,Surgery Building, RG Kar Medical College and Hospital to compare the effectiveness of the post-operative analgesic effect of ultrasound guided modified BRILMA block versus subcostal transversus abdominis plane block in open cholecystectomy. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ThePatients posted for open cholecystectomy surgery. 
 
ExclusionCriteria 
Details  1) Uncooperative patients
2) Cardiac and neurological diseases
3) Uncontrolled diabetes and hypertension
4) Known allergy to the drug used
5) Epilepsy
6) Any kind of preexisting neuropathy
7) Alcoholism
8) Chronic opioid use (defined as daily use of opioid for more than 3 month) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Postoperative analgesia measured by VAS (Visual analogue scale) score at 0, 6, 12, 24 hours.
2) Time to rescue analgesia and number of doses required in first 24 hours. 
1) Postoperative analgesia measured by VAS (Visual analogue scale) score at 0, 6, 12, 24 hours.
2) Time to rescue analgesia and number of doses required in first 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Evaluation of postoperative hemodynamic response for 1 week or until the day of discharge.
2) Patients’ satisfaction  
From the day of surgery to 1 week or until the day of discharge 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   14/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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-identification.

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 31-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study will be initiated after obtaining approval of Institutional Ethics Committee and informed consent from all patients. Following a detailed pre anesthetic checkup, the patients fulfilling the inclusion criteria will be allocated in one of the two groups e.g. Group B (ultrasound guided modified BRILMA block with injection bupivacaine 0.25%) and Group T (ultrasound guided subcostal transversus abdominis plane block with injection bupivacaine 0.25%) All patients will receive general anaesthesia according to a standard protocol with ASA monitoring after securing IV line with an 18G cannula. Blood pressure, (systolic, diastolic and mean), Heart Rate, ECG, Spo2, Respiratory Rate, ETCO2 will be monitored. After induction of general anesthesia before skin incision, ultrasound guided modified BRILMA block and subcostal transversus abdominis plane block will be administered to the respective group. Proper needle placement will be noted by ultrasound guidance. After correct placement of the needle, the drug (Injection bupivacaine 0.25% 20ml on one side) will be injected after a negative aspiration of blood .For performing modified BRILMA block, the patient was placed in left lateral decubitus with the probe in the sagittal plane at the mid-axillary line at the level of the eighth rib on the right side. The fascial plane between the serratus anterior muscle and the external intercostal muscle was identified. The needle was introduced by an in-plane technique and after confirmation by hydro dissection; 20 mL of 0.25% bupivacaine was administered into the serratus-intercostal fascial plane under ultrasound guidance to visualize the spread of the LA solution. Ultrasound-guided Subcostal TAP block was performed in the supine position with the probe placed below the xiphisternum in the transverse plane and moved laterally parallel to the right costal margin to visualize the muscle layers of the anterior abdominal wall and by in-plane technique. The subcostal TAP plane (between the posterior sheath of rectus abdominis and transversus abdominis muscles) was confirmed by hydro dissection and 20 mL of 0.25% bupivacaine was administered. Then the data will be collected according to the case record form. All the blocks were done by a single experienced anesthesiologist. 
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