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CTRI Number  CTRI/2025/07/091725 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study on the use of M - TAPA Nerve block for reducing pain after Laparoscopic Cholecystectomy  
Scientific Title of Study   EFFICACY OF PREEMPTIVE ULTRASOUND - GUIDED MODIFIED THORACOABDOMINAL NERVE BLOCK THROUGH PERICHONDRIAL APPROACH (M -TAPA) FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA.  
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 Rekha S 
Designation  Post Graduate 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura Main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9113295376  
Fax    
Email  appirekha5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Vijaykumar Kadlimatti 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9008229914  
Fax    
Email  deepakkadlimatti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rekha S 
Designation  Post Graduate 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9113295376  
Fax    
Email  appirekha5@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar medical college and hospital Bangalore 
 
Primary Sponsor  
Name  Dr Rekha S 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Bangalore Karnataka India 560045  
Type of Sponsor  Other [] 
 
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 Rekha S  Dr B R Ambedkar medical college and hospital  Department of Anaesthesiology 1st floor Shampura main road Kadugondanahalli Bangalore 560045
Bangalore
KARNATAKA 
9113295376

appirekha5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral Modified Thoracoabdominal nerve block through perichondrial approach  Patients posted for elective laparoscopic cholecystectomy will be given preemptive ultrasound guided bilateral modified thoracoabdominal nerve block through perichondrial approach using Inj Bupivacaine 0.25% 20ml with Inj Dexamethasone 4mg 
Comparator Agent  Not appicable  Not applicable. Single arm interventional study. No comparator used. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients posted for elective laparoscopic cholecystectomy under general anaesthesia 2. Patients aged between 18 to 75y 3. Patients belonging to American Society of Anaesthesiologists Physical status 1 and 2 
 
ExclusionCriteria 
Details  1. Known allergy to the local anaesthetics given.
2. Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
3. Patients with dementia or cognitive problems.
4. Patients with BMI greater than 35kg/m2.
5. Coagulopathy or patients on anti-coagulants
6. Known case of Diabetes mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of postoperative analgesia following laparoscopic cholecystectomy  For first 24 postoperative hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate analgesic consumption in first 24 postoperative hours.
To assess the incidence of adverse effects like nausea, vomiting. 
FROM THE TIME OF BLOCK UPTO 24H AFTER THE BLOCK 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   N/A 
Date of First Enrollment (India)   04/08/2025 
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="6"
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  
Laparoscopic cholecystectomy brings benefits such as less pain, shorter hospital stay, and earlier recovery, and it is a cost-effective procedure. Though it is known for its minimally invasive nature, postoperative pain management remains challenging. Poorly controlled early postoperative pain impairs the quality of recovery, increasing the risk of postoperative pulmonary complications. It was observed that the abdominal pain following Laparoscopic cholecystectomy mostly originates from the incision area, and the remaining part consists of visceral and referred pain. Among various regional techniques, the subcostal transversus abdominis plane block  is a regional analgesic technique that can provide analgesia of the supraumbilical abdomen and has showed greatest reduction in pain score at 12hours postoperatively compared with other regional analgesic techniques. Modified Thoracoabdominal nerve block through perichondrial approach, which administers local anaesthetics only between the costal cartilage and the transverse abdominis muscle which provides wide blockage area that includes T5 and T11 to T12 dermatomal levels because the applied local anaesthetics also passes the linea semilunaris. It also has an advantage of performing the block in supine position
In this background the research question of the present study is to assess the duration of postoperative analgesia following  laparoscopic cholecystectomy using Inj Bupivacaine 0.25 percent.
 
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