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
|
|
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
|
|
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) Patientsā 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maanikaandaan@gmail.com].
- 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.
- 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. |