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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Thesis plan

  6. 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.

  7. 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.

 
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