| CTRI Number |
CTRI/2026/01/101452 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bilateral Modified Thoracoabdominal Nerve Block via Perichondrial Approach Versus Port-Site Infiltration for Postoperative Analgesia Following Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
To Study Bilateral Modified Thoracoabdominal Nerve Block Through The Perichondrial Approach Versus Port Site Infiltration For Post Operative Pain Relief After 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 |
Dr Gurpreeti Kaur |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana, 141001, Punjab, India
Ludhiana PUNJAB 141001 India |
| Phone |
9779552017 |
| Fax |
|
| Email |
grewal.preeti@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankita Heer |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana, 141001, Punjab, India
Ludhiana PUNJAB 141001 India |
| Phone |
8284985818 |
| Fax |
|
| Email |
heerankita18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ankita Heer |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana, 141001, Punjab, India
Ludhiana PUNJAB 141001 India |
| Phone |
8284985818 |
| Fax |
|
| Email |
heerankita18@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil Lines, Ludhiana, 141001, Punjab, India |
| Type of Sponsor |
Private 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 Ankita Heer |
Dayanand Medical College and Hospital |
Department of Anaesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana, Punjab, 141001 Ludhiana PUNJAB |
8284985818
heerankita18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee, Dayanand Medical College and Hospital |
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 |
| Comparator Agent |
0.2% 20mL Ropivacaine |
Group M : Patients will receive Bilateral Ultrasound guided M-TAPA block with 10mL of 0.2% Ropivacaine on each side (total volume 20 mL) after induction of general anaesthesia |
| Comparator Agent |
0.2% 20mL Ropivacaine |
Group P : Patients will receive infiltration of Local Anaesthesia, 20mL of 0.2% Ropivacaine , divided equally amongst the four Port Site incisions (5mL at each port) |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, age 18 years and above, American society of Anaesthesiologists(ASA)grade 1 and 2, undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients allergic to Ropivacaine, Infection at site of injection, Patients undergoing emergency surgery, patients with coagulopathies, refusal to participate in the study, patients unable to comprehend NRS score, Pregnant patients and patients with BMI more than 35. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time of requirement for first rescue analgesic in patients in both groups undergoing laparoscopic cholecystectomy under general anaesthesia |
The time of requirement for first rescue analgesic in patients in both groups undergoing laparoscopic cholecystectomy under general anaesthesia, till 24 hours post operatively, assessed at regular interval of time after sugery completeion till 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total consumption of total rescue analgesic (tramadol) in first 24 hrs after surgery in both groups. |
First 24 hours after surgery |
| To compare effect on hemodynamic parameters : heart rate & blood pressure at 0,2,4,6,12,18, 20 & 24 hrs |
Post operatively upto 24 hours, starting from 0,2,4,6,12,18,20 & 24hours |
| NRS pain scores at 0,2,4,6,12,18, 20 & 24hrs |
Post operatively upto 24 hours, starting from 0,2,4,6,12,18,20 & 24hours |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/01/2026 |
| 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="6" Days="29" |
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Thesis plan
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Postoperative pain following laparoscopic cholecystectomy remains a significant clinical issue due to its multifactorial origin and potential to delay recovery if inadequately controlled. In accordance with Enhanced Recovery After Surgery (ERAS) principles, multimodal analgesia incorporating ultrasound-guided regional techniques is increasingly emphasized to enhance analgesia while minimizing opioid consumption. The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is an emerging regional analgesic technique that targets the thoracoabdominal nerves (T6–T12) by depositing local anaesthetic beneath the costal cartilage, potentially providing more effective and extensive analgesia than conventional transversus abdominis plane blocks. This randomized controlled study aims to compare the postoperative analgesic efficacy of bilateral ultrasound-guided M-TAPA block and port-site local anaesthetic infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Patients will be randomly allocated into two groups: Group M will receive a bilateral ultrasound-guided M-TAPA block with 20 ml of 0.2% ropivacaine administered on each side, while Group P will receive 20 ml of 0.2% ropivacaine infiltrated equally across the four laparoscopic port sites. The results of this study are expected to clarify the relative effectiveness of these two analgesic approaches and support optimization of postoperative pain management with reduced opioid requirements following laparoscopic cholecystectomy. |