| CTRI Number |
CTRI/2025/09/095026 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two ultrasound guided Nerve Block Techniques for pain relief after Laparoscopic Gallbladder removal surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided Modified Thoraco-Abdominal nerve block through Perichondrial Approach(M-TAPA) with ultrasound guided Subcostal Transversus Abdominis Plane(TAP) block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI KUMARI |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital |
| Address |
Room no-301, third floor Department of Anaesthesia, ABVIMS and Dr RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7665603056 |
| Fax |
|
| Email |
drjyoti0706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAMITA ARORA |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital |
| Address |
Room no-301, third floor Department of Anaesthesia, ABVIMS and Dr RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAMITA ARORA |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital |
| Address |
Room no-301, third floor Department of Anaesthesia, ABVIMS and Dr RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr Ram Manohar Lohia Hospital, Baba Kharak Singh Mark, New Gurudwara Bangla Sahib, Connaught Place, New Delhi, 110001 New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Room no-301, third floor, Department of Anaesthesia, ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi 110001 |
| 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 Jyoti Kumari |
ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi |
Room no-301, third floor Department of Anaesthesia, ABVIMS and Dr RML Hospital New Delhi
New Delhi
DELHI |
7665603056
drjyoti0706@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analgesic effect of two different Nerve Blocks |
Difference between postoperative analgesic effects of two different nerve blocks in patients undergoing laparoscopic cholecystectomy. |
| Intervention |
Ultrasound guided Nerve Blocks |
Comparison of ultrasound guided Modified Thoraco-abdominal Nerve Block through Perichondrial approach(M-TAPA) with ultrasound guided Subcostal Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years
2.Patients of ASA status I and II
3.Patients undergoing Laparoscopic cholecystectomy under general anesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patients allergic to local anaesthetics
2.Pre-existing coagulation disorders
3.Pregnancy
4.BMI greater than 35 kg/m2
5.Previous history of abdominal surgery or trauma
|
|
|
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 |
| Total dose of Tramadol consumed (mg) in first 24hours. |
24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Time to demand the rescue analgesic (TRAMADOL) in hours.
-NRS Score at rest and coughing at 0,1,3,6,12 and 24. |
0,1,3,6,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/09/2025 |
| 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="5"
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
|
This randomized controlled study aims to compare the efficacy of two regional anesthesia techniques—M-TAPA and subcostal TAP block—in providing postoperative analgesia for patients undergoing laparoscopic cholecystectomy under general anesthesia. While subcostal TAP block is an established technique targeting the T6–T9 dermatomes, its effect on visceral pain is limited. The novel M-TAPA block is believed to provide a broader somatic and potentially visceral blockade (T5–T12) by depositing local anesthetic under the perichondrium of the costal cartilage. The study will evaluate total tramadol consumption in the first 24 hours postoperatively as the primary outcome. Secondary outcomes include pain scores (NRS), time to first rescue analgesic, time taken to perform the blocks, and block-related complications. |