| CTRI Number |
CTRI/2025/04/084379 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Ultrasound-Guided Nerve Block Techniques to Manage Pain After Keyhole Gallbladder Surgery
|
|
Scientific Title of Study
|
To Assess The Postoperative Analgesic Efficacy Of Ultrasound- Guided External Oblique Intercostal Fascial Plane Block Versus Subcostal Transversus Abdominis Plane Block In Laparoscopic Cholecystectomy Under General Anaesthesia. |
| 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 Merin Varghese |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital |
| Address |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital K G Halli Bengaluru 560045 Karnataka
India
Bangalore
KARNATAKA
560045
India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Merin Varghese |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital |
| Address |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital K G Halli Bengaluru
560045 Karnataka 560045 India
Bangalore
KARNATAKA
560045
India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Merin Varghese |
| Designation |
Associate Professor |
| Affiliation |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital |
| Address |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital K G Halli Bengaluru
560045 Karnataka 560045 India
560045 KARNATAKA 560045 INDIA Bangalore KARNATAKA
Bangalore
KARNATAKA
560045
India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital
|
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital |
| Address |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital K G Halli Bengaluru
560045 Karnataka 560045 India
|
| Type of Sponsor |
Private 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 Merin Varghese |
Major OT complex |
Department Of Anaesthesiology Dr Br Ambedkar Medical College And Hospital K G Halli Bengaluru 560045 Karnataka
560045 Karnataka 560045 India
Bangalore
KARNATAKA |
08547502337
merinvv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Unilateral External Oblique Intercostal Fascial plane block |
Ultrasound guided Unilateral External Oblique Intercostal
Fascial plane block using 20 ml of 0.2% Ropivacaine and Dexamethasone 4mg. |
| Comparator Agent |
Unilateral Subcostal Transversus Abdominis Plane Block |
Ultrasound guided unilateral subcostal Transversus Abdominis Plane block using 20 ml of 0.2% Ropivacaine and Dexamethasone 4 mg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for laparoscopic cholecystectomy requiring general anesthesia.
Patients between the ages of 18-65years.
Patients belonging to American Society of Anesthesiologists physical status (ASA- PS)
I, II . |
|
| ExclusionCriteria |
| Details |
Patient with refusal of injection at the site of block.
Any other additional surgical interventions or conversion to open surgery
Patients with drug allergy or history of allergy to amide-type local anesthetics,
Patients with a history of narcotic drug use, chronic pain, narcotic substance or alcohol
abuse.
Patients with known severe heart, kidney, liver, life-threatening hematological diseases
Patients with psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the postoperative analgesic effect of External Oblique Intercostal Fascial Plane Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy under general anaesthesia.
|
Every 2 hours for the first 24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
Post operative VAS score at 0,6,12,24 hours
Timing for the first rescue analgesia
Post operative 24 hours total analgesia consumption.
Patient satisfaction score in both groups.
Complications if any (postoperative nausea and vomiting, hematoma at the injection site, intravascular injection, hypertension, etc).
|
Every 2 hours for the first 24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
23/04/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Prospective, double-blinded, interventional trial comparing the analgesic efficacy of two regional anesthesia techniques—Unilateral External Oblique Intercostal Fascial Plane Block (EOIB) and Subcostal Transversus Abdominis Plane Block (TAPB)—in patients undergoing laparoscopic cholecystectomy under general anesthesia.The study aims to evaluate postoperative pain relief by assessing Visual Analogue Scale (VAS) scores at multiple time intervals (0, 6, 12, and 24 hours), the timing of first rescue analgesia, total 24-hour analgesic consumption, patient satisfaction, and any complications. A total of 42 patients will be randomly assigned to either EOIB or TAPB groups, receiving ultrasound-guided nerve blocks with 20 ml of 0.2% Ropivacaine and 4 mg of Dexamethasone post-surgery. The study’s hypothesis suggests that EOIB may provide superior analgesia due to its ability to block both anterior and lateral cutaneous branches of the intercostal nerves. Findings from this research could influence post-laparoscopic cholecystectomy pain management protocols by optimizing regional anesthesia techniques to minimize opioid use and enhance patient recovery. |