| CTRI Number |
CTRI/2025/03/083698 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two nerve blocks, external oblique intercostal plane nerve block and subcostal transversus abdominis plane nerve block for post operative pain in patients operated for laparoscopic gallbladder removal |
|
Scientific Title of Study
|
Comparison of Ultrasound guided External oblique intercostal plane block vs subcostal transversus abdominis plane block for laparoscopic cholecystectomy surgeries: a prospective randomised controlled clinical study |
| 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 Gopinath Reddy |
| Designation |
Post graduate student |
| Affiliation |
AIIMS, Raipur |
| Address |
4 th floor, B block, Department of Anesthesiology and Critical care, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8639593015 |
| Fax |
|
| Email |
gnreddy0911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
4 th floor, B block, Department of Anesthesiology and Critical care, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
4 th floor, B block, Department of Anesthesiology and Critical care, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, All India Institute of Medical Sciences, Tatibandh, Raipur- 492099 |
|
|
Primary Sponsor
|
| Name |
Dr Gopinath Reddy |
| Address |
Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Gopinath Reddy |
All India Institute of Medical Sciences Raipur |
Department of Anesthesiology, 4 th floor, B block, AIIMS Raipur
Raipur
CHHATTISGARH |
8639593015
gnreddy0911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Oblique Intercostal plane block |
0.25% Bupivacaine + 4mg Dexamethasone will be deposited bilaterally in the plane between External Oblique muscle and 6 & 7 ribs with associated Intercostal muscles under Ultrasound guidance |
| Comparator Agent |
Subcostal Transversus Abdominis Plane Block |
0.25% Bupivacaine 20ml + 4mg Dexamethasone will be deposited bilaterally in between Internal Oblique muscle and Transversus Abdominis Muscle under Ultrasound Guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA status of 1,2 and 3
BMI between 18-35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Infection at the site of injection
Coagulopathy
Allergy to study drugs
Pregnant and Lactating females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To record time taken for first rescue analgesic requirement |
From extubation till 24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO CALCULATE THE DOSE OF TRAMADOL AND DICLOFENAC REQUIREMENT POSTOPERATIVELY
TO ASESS POSTOPERATIVE PAIN BY VAS AT 1h,2h,3h,6h,12h,24h |
First 24 hrs AFTER SURGERY |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
All eligible patients will be well explained about the study protocol and interventions and allocated into two groups. Patients will be taken to the operating room, and anesthesia will be induced as per institutional protocol. After the surgery is completed, one group will be given external oblique intercostal plane block, and in the other group, subcostal transversus abdominis plane block will be given with ultrasound guidance. Then, the patient will be reversed from anesthesia and shifted to the postoperative recovery room and monitored. Postoperative pain will be assessed with the Visual Analogue Scale for the first 24 hours. If the patient complains of pain (Visual analogue scale score more than 4), rescue analgesia (tramadol and diclofenac) will be given, and time will be noted. This data will be analyzed statistically. Finally, the primary outcome (time taken for first postoperative rescue analgesia) will be compared in both groups. |