| CTRI Number |
CTRI/2025/08/093674 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief after gallbladder keyhole surgery: comparing a new nerve block (M-TAPA) with routine local injection and pain medicines |
|
Scientific Title of Study
|
Comparison of Modified Thoracoabdominal Nerve
Block Through Perichondrial Approach (M-TAPA) versus Port-
Site local Infiltration and Opioid based Analgesia in Laparoscopic
Cholecystectomy: A Prospective, Randomized Control Study" |
| Trial Acronym |
M-TAPA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Degutla Karthik Chary |
| Designation |
Junior Consultant anaesthesiologist |
| Affiliation |
|
| Address |
Department of anaesthesiology, AIG Hospitals, Gachibowli, hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8328535344 |
| Fax |
|
| Email |
Kd95.work@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Degutla Karthik Chary |
| Designation |
Junior Consultant anaesthesiologist |
| Affiliation |
|
| Address |
Department of anaesthesiology, AIG Hospitals, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8328535344 |
| Fax |
|
| Email |
Kd95.work@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Degutla Karthik Chary |
| Designation |
Junior Consultant anaesthesiologist |
| Affiliation |
|
| Address |
Department of anaesthesiology, AIG Hospitals, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8328535344 |
| Fax |
|
| Email |
Kd95.work@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Degutla Karthik Chary |
| Address |
AIG Hospitals, 1-66/AIG/2 to 5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Degutla Karthik Chary |
AIG Hospitals |
AIG Hospitals, Department of anaesthesiology, 1-66/AIG/2 to 5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
8328535344
Kd95.work@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) |
Administered after induction of general anesthesia, before surgical incision. Bilateral injections under ultrasound guidance at the level of the 10th costal cartilage, in the fascial plane between the transversus abdominis muscle and costal cartilage. 20 ml of 0.2 percent ropivacaine on each side with 21 G 100 mm echogenic needle. |
| Comparator Agent |
Port Site Infiltration |
Administered at the end of surgery.Direct infiltration of port sites under aseptic precautions. 0.2 percent ropivacaine 20 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status 1,2,3
Elective laparoscopic cholecystectomy under general anesthesia
Patients who provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA 4 or higher
Emergency or open cholecystectomy
Coagulopathy or anticoagulant therapy
Local infection at block site
Allergy to local anesthetics
Chronic opioid use or chronic pain disorder
Severe hepatic or renal impairment
|
|
|
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 |
| Postoperative pain scores using Numeric Rating Scale (NRS, 0–10) |
At immediate post operative period or 0 hours, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total opioid consumption in 24 hours (IV tramadol/fentanyl equivalent) intraoperative and postopertive |
cumulative intraoperative and postoperative |
| Hemodynamic response to surgical stimulus (MAP and HR) |
At trocar insertion, 5, 10, 15 min after pneumoperitoneum, and at extubation |
| Hemodynamics in postoperative period (MAP and HR) |
At 1, 2, 4, 8, 12, and 24 hours postoperatively
|
| Incidence of postoperative nausea and vomiting (PONV) |
0–24 hours postoperatively |
| Patient satisfaction score (Likert scale) |
At 24 hours
|
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
05/09/2025 |
| 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="0"
Months="2"
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
|
This randomized, parallel group, active controlled clinical trial will evaluate the analgesic efficacy of ultrasound guided Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M TAPA) compared with conventional port site infiltration with local anesthetic in patients undergoing laparoscopic cholecystectomy. 113 adult patients (ASA I to III, aged 18 to 75 years) scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomized into two groups. Group A will receive bilateral M TAPA block after induction of anesthesia, while Group B will receive conventional port site infiltration with local anesthetic. The primary outcome will be postoperative pain scores assessed using the Numeric Rating Scale at predefined time intervals up to 24 hours. Secondary outcomes include total opioid consumption, intraoperative and postoperative hemodynamic responses, incidence of postoperative nausea and vomiting, sedation scores, return of bowel function, and patient satisfaction. This study aims to determine whether M TAPA provides superior analgesia, reduces opioid requirements, and improves recovery compared to routine practice. |