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.

Not yet recruiting

• Conditions: Acute cholecystitis,

• Registration Number: CTRI/2025/04/083792
• Lead Sponsor: R G Kar Medical College and Hospital

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-31
• Study Start: 2025-04-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

ThePatients posted for open cholecystectomy surgery.

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Postoperative analgesia measured by VAS (Visual analogue scale) score at 0, 6, 12, 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.
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 Measures

Name	Time	Method
1) Evaluation of postoperative hemodynamic response for 1 week or until the day of discharge.	2) Patients’ satisfaction

Trial Locations

Locations (1)

R.G. Kar Medical College and Hospital, Kolkata.; 🇮🇳 Kolkata, WEST BENGAL, India

R.G. Kar Medical College and Hospital, Kolkata.

🇮🇳Kolkata, WEST BENGAL, India

Dr Bani Parvati Magda Hembrom

Principal investigator

9903207690

banihembrom72@gmail.com