FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be shared only on request

  6. 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.

  7. 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.

 
Close