| CTRI Number |
CTRI/2025/11/097856 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing ultrasound guided MODIFIED THORACOABDOMINAL NERVE BLOCK VIA PERICHONDRIAL APPROACH (M-TAPA) AND EXTERNAL OBLIQUE AND RECTUS ABDOMINIS PLANE (EXORA) block application for pain relief after laparoscopic gallbladder removal surgery |
|
Scientific Title of Study
|
A randomized, double - blind, comparative evaluation of the efficacy of usg guided MODIFIED THORACOABDOMINAL NERVE BLOCK VIA PERICHONDRIAL APPROACH (M-TAPA) AND EXTERNAL OBLIQUE AND RECTUS ABDOMINIS PLANE (EXORA) block application for analgesia after laparoscopic cholecystectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arshima Khokher |
| Designation |
Junior resident |
| Affiliation |
Chhatrapati Shivaji Subharti Hospital, Swami Vivekanand Subharti University |
| Address |
Department of Anaesthesiology and Critical care, Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, NH 58, Delhi Haridawar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9996055365 |
| Fax |
|
| Email |
arshimak20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasundhera Tyagi |
| Designation |
Associate Professor |
| Affiliation |
Chhatrapati Shivaji Subharti Hospital, Swami Vivekanand Subharti University |
| Address |
Department of Anaesthesiology and Critical care, Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, NH 58, Delhi Haridawar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9354956507 |
| Fax |
|
| Email |
drvasundhera13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasundhera Tyagi |
| Designation |
Associate Professor |
| Affiliation |
Chhatrapati Shivaji Subharti Hospital, Swami Vivekanand Subharti University |
| Address |
Department of Anaesthesiology and Critical care, Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, NH 58, Delhi Haridawar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9354956507 |
| Fax |
|
| Email |
drvasundhera13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Medical College, Chhatrapati Shivaji Subharti Hospital, Subhartipuram, Nh-58 Delhi Haridwar Bypass, Meerut, 250005, india. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Arshima Khokher |
Chhatrapati Shivaji Subharti Hospital, Swami Vivekanand Subharti University |
Department of Anaesthesiology and Critical care, Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, NH 58, Delhi Haridawar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
9350124532
arshimak20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University ethics committee (medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% Bupivacaine |
0.3ml/kg of 0.25% Bupivacaine usg guided EXTERNAL OBLIQUE AND RECTUS ABDOMINIS PLANE (EXORA) block application for analgesia after laparoscopic
cholecystectomy |
| Intervention |
0.25% Bupivacaine |
0.3ml/kg of 0.25% Bupivacaine usg guided MODIFIED THORACOABDOMINAL NERVE BLOCK VIA PERICHONDRIAL APPROACH (M-TAPA) block application for analgesia after laparoscopic cholecystectomy Edit || Delete |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 18 and 65 years
2 Classified as ASA Physical Status I or II
3 Either sex M/F
|
|
| ExclusionCriteria |
| Details |
1 Allergy to the study drug
2 Coagulopathy or current anticoagulant therapy
3 Infection at the injection site
4 Inability to visualize the plane on USG
5 Pregnancy or lactation
6 Uncontrolled diabetes mellitus
7 Cardiorespiratory disorder (e.g bronchial asthma, bradyarrythymias, heart block, CAD)
8 Hepatic, neurological or renal disease
9 Psychiatric disorder
10 Patient using chronic analgesic medication
11 Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Comparison of the pain scores post operatively in both the groups (M-TAPA & EXORA).
2 Comparison of the time of first analgesic demand and the total amount of rescue analgesic consumption during the first 12 and 24 hours of postoperative period.
|
Two years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Comparison of the overall patient satisfaction scores among both groups.
2 Comparison of the hemodynamic parameters after the procedure.
3 Recording and comparing the incidence of any side effects
|
Two years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2025 |
| 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="2"
Months="0"
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
|
The aim of this randomized, double-blind study is to compare the efficacy of USG guided Modified Thoracoabdominal Nerve Block via Perichondrial Approach (M-TAPA) and the External Oblique and Rectus Abdominis Plane (EXORA) block in providing postoperative analgesia for patients undergoing laparoscopic cholecystectomy. Primary Objectives 1. To compare the pain scores post operatively in both the groups (M-TAPA & EXORA). 2. To compare the time of first analgesic demand and the total amount of rescue analgesic consumption during the first 12 and 24 hours of postoperative period. Secondary Objectives 1. To compare the overall patient satisfaction scores among both groups. 2. To compare the hemodynamic parameters after the procedure. 3. To record and compare the incidence of any side effects. |