| CTRI Number |
CTRI/2026/01/102368 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing two ultrasound based pain control method after gall bladder surgery |
|
Scientific Title of Study
|
A Prospective Randomized Study Comparing Ultrasound-Guided External Oblique Intercostal Plane Block and Modified Thoracoabdominal Nerve Block Through a Perichondrial Approach m-TAPA in Adult Patients Undergoing Elective Laparoscopic Cholecystectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avanish Kumar vishwakarma |
| Designation |
Senior resident |
| Affiliation |
LLRM medical college |
| Address |
Room number 10 department of anaesthesia LLRM medical college meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8584998729 |
| Fax |
|
| Email |
akvish92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sweta |
| Designation |
Associate professor |
| Affiliation |
LLRM medical college |
| Address |
Room no -10 department of anaesthesia LLRM medical college meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
Swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avanish Kumar vishwakarma |
| Designation |
Senior resident |
| Affiliation |
LLRM medical college |
| Address |
Room number 10 department of anaesthesia LLRM medical college meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8584998729 |
| Fax |
|
| Email |
akvish92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia LLRM medical college meerut india pin code250004 |
|
|
Primary Sponsor
|
| Name |
Dr avanish Kumar vishwakarma |
| Address |
Room number 10 department of anaesthesia LLRM medical college meerut india pin code 250004 |
| 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 jheelam singh |
Sardar vallabhbhai hospital meerut |
Room number 10 group floor department of anaesthesia
Meerut
UTTAR PRADESH |
6398478017
Jheelamsingh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the principal ,LLRM medical college,meerutInstitutional Ethical commitee |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ulta sound guided external oblique intercostal plane block and ultrasound guided modified thoraco abdominal nerva block using ropivacaine 0.25% concentration total volume 30 ml! |
In group A in ultrasound guided external oblique intercostal plane block used drugs local anaesthetic ropvivacaine 0.25%% total volume 30 ml and and group B USG guided modified thoraco abdominal nerve block will be use 0.25 @% ropivacaine 30 ml in volume .under ultrasound guided after visualization of fascial plane using echogenic needle local anaesthetic will be infiltration after proper negative aspiration and all standards of anaesthesia care!! After performing block all observations will be done according research protocol |
| Intervention |
Ultra sound guided external oblique intercostal plane block and ultrasound guided modified thoraco abdominal nerve block through a perichondrial approach |
Intervention will be done under ultrasound guided and after proper visualization of anatomical structure drugs will be infiltration after proper negative aspiration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1 and 2 patient
Elective surgery procedure |
|
| ExclusionCriteria |
| Details |
Any hypersensitivity reaction to.local anaesthetic
Local site infection
Any comorbid condition
Any history of hypertension tuberculosis heart disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of post operative analgesia |
Over 24 hour post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total assessment total analgesic consumption |
Over last 24 hour period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomised comparative study to compare USG guided external oblique intercostal plane block and ultrasound guided modified thoraco abdominal nerve block through peri condrial approach in adults patient undergoing laproscopic surgery for evaluation nof post operative analgesic and total analgesic consumption in last 24 hour in post operative period |