| CTRI Number |
CTRI/2025/11/098007 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| 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 types of nerve blocks for pain relief after gallbladder surgery |
|
Scientific Title of Study
|
Comparison of modified thoracoabdominal nerve block (MTAPA) vs external oblique plane block (EOI) in patients undergoing laparoscopic cholecystectomy: A prospective randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Swaroop |
| Designation |
Junior Resident |
| Affiliation |
All Inida Institute of Medical Sciences Nagpur |
| Address |
Department of Anesthesia, AIIMS Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
9889944524 |
| Fax |
|
| Email |
swaroop0512@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ridhima Sharma |
| Designation |
Associate Professor |
| Affiliation |
All Inida Institute of Medical Sciences Nagpur |
| Address |
Department of Anesthesia, AIIMS Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
8054549458 |
| Fax |
|
| Email |
drridhimasharma@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Nidhi Swaroop |
| Designation |
Junior Resident |
| Affiliation |
All Inida Institute of Medical Sciences Nagpur |
| Address |
Department of Anesthesia, AIIMS Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
9889944524 |
| Fax |
|
| Email |
swaroop0512@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Nagpur Department of Anesthesiology |
| Address |
1st floor, IPD building, AIIMS Nagpur, Mihan, Nagpur, Maharashtra |
| 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 Nidhi Swaroop |
AIIMS Nagpur |
Department of Anesthesiology, First floor, IPD building Nagpur MAHARASHTRA |
9889944524
swaroop0512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
External oblique plane block |
The external oblique plane block is an ultrasound- guided regional anesthesia technique. Local anesthetic is deposited between the external oblique and intercostal muscles near the costal margin, targeting anterior branches of thoracoabdominal nerves (T7-T11). It provides effective analgesia for upper abdominal procedures, especially laparoscopic cholecystectomy and upper midline incisons. It will be done immediately after induction and the effect of the block will be for 8 hours. |
| Intervention |
Modified Thoracoabdominal Nerve Block |
The Modified thoracoabdominal nerve block through perichondrial approach is an ultrasound guided regional technique. Local anesthetic is injected between the transversus abdominis and the lower surface of costal cartilage, targeting thoracoabdominal nerves to provide effective analgesia for upper abdominal surgeries like laparoscopic cholecystectomy. It will be done immediately after induction and the effect of the block will be for 8 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- Patients classified as American society of Anesthesiologists (ASA) physical status I-II.
2- Patients scheduled for elective laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
1- Patients on anticoagulant therapy
2- Presence of coagulopathy
3- Known allergies to local anesthesia
4- Local infection at block site
5- Inability to comprehend or assess pain ratings and recovery quality scoring systems |
|
|
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 |
| Measurement of cumulative opioid consumption |
First 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Comparison of intraoperative & postoperative hemodynamic stability.
2- Numerical rating scale (NRS) scores at rest & during activity.
3- Untoward side effects, including nausea, vomiting, hypotension & bradycardia.
4- QoR-15 patient questionnaire score. |
1- In first 24 hours
2- At 0 min,30 min, 1hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour
3- Within 24 hours
4- At 24 hours |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
16/12/2025 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be shared only on request
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This single center prospective randomized clinical trial is being conducted at the department of anaesthesiology aiims nagpur to compare the postoperative analgesic efficacy of ultrasound guided modified thoracoabdominal nerves block through perichondrial approach mtapa and external oblique intercostal eoi block in patients undergoing elective laparoscopic cholecystectomy. Despite laparoscopic cholecystectomy being a minimally invasive procedure postoperative pain remains a significant concern attributed to incisional visceral and peritoneal pain mechanisms. Multimodal analgesia including regional anesthesia techniques has emerged as a key strategy in postoperative pain control.This study hypothesizes that the mtapa block by targeting thoracoabdominal nerves from T4 to T12 dermatomes will offer superior analgesic outcomes and reduce opioid consumption compared to the eoi block which targets the lateral and anterior cutaneous branches of intercostal nerves T6 to T11. Seventy adult patients aged 18 to 65 years and classified as asa physical status I and II will be randomized into two groups of 34 each. Both blocks will be performed using ultrasound guidance by a trained anesthesiologist while postoperative pain scores and opioid consumption will be assessed by a blinded observer. Primary outcome is total opioid consumption within 24 hours postoperatively. Secondary outcomes include intraoperative and postoperative hemodynamic stability, pain scores atvarious time intervals using the numerical rating scale and assessment of recovery using a questionnaire. Any adverse effects such as nausea vomiting or bradycardia will also be recorded. Data will be statistically analyzed using a statistical software. This study aims to provide evidence on the comparative efficacy of mtapa and eoi blocks in enhancing postoperative recovery and analgesia potentially guiding future anesthesia protocols for laparoscopic surgeries. |