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CTRI Number  CTRI/2024/02/062488 [Registered on: 09/02/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nerve block for postoperative pain relief]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   M-TAPA nerve block for pain relief in laparoscopic gall bladder operation  
Scientific Title of Study   Efficacy of modified thoracoabdominal nerve block via perichondrial approach (M-TAPA) for postoperative pain relief 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  Dr Mamta Jain 
Designation  Associate professor 
Affiliation  Pt B D Sharma PGIMS 
Address  Department of anaesthesiology and critical care Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9958437432  
Fax    
Email  mamtajainsingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Jain 
Designation  Associate professor 
Affiliation  Pt B D Sharma PGIMS 
Address  Department of anaesthesiology and critical care Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9958437432  
Fax    
Email  mamtajainsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Vikas Kumar 
Designation  Junior Resident  
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Department of anaesthesiology and critical care Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8168889064  
Fax    
Email  kesusoni1998@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology and critical care,PGIMS,Rohtak,Haryana,124001,India 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak haryana  
Address  Department of anaesthesiology and critical care Pt B D Sharma PGIMS Rohtak Haryana 124001 
Type of Sponsor  Government 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 
Vikas Kumar  Pt B D Sharma PGIMS Rohtak   Department of anaesthesiology and critical care Pt B D Sharma PGIMS
Rohtak
HARYANA 		 8168889064

kesusoni1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee Pt B D Sharma PGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified-Thoracoabdominal nerve block through Perichondrial approach (M-TAPA) in intervention group  M-TAPA block will be performed bilaterally in intervention group after the induction of general anaesthesia under ultrasound guidance with 0.25% Bupivacaine 20ml each on both sides.  
Comparator Agent  NO M-TAPA block in control group,conventional methods of analgesia to be given for pain management   In control group, no M-TAPA block will be given after induction of general anaeathesia.Conventional methods of analgesia will be given in control group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients aged 18 to 65 years of either sex with American Society of Anesthesiologists(ASA) physical status I or II scheduled to undergo laparoscopic cholecystectomy under general anaesthesia  
 
ExclusionCriteria 
Details  1.Coagulopathies
2.Allergic reactions to local anaesthetic
3.Infection at the block site
4.Pregnancy
5.Weight less than 50 kg
6.History of abdominal surgery or trauma
7.Refusal to give consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Analgesic consumption  in initial 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain score evaluation using visual analogue scale
Time to first analgesic request.
Total intraoperative fentanyl consumption.
Number of dermatomes anaesthetised.
Adverse effects (if any)
 		 total fentanyl consumption intraoperatively
VAS score at PACU admission, first rescue analgesic request 2h, 4h, 6h and 24h postoperatively
dermatomes blocked and side effect postoperatively
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 17/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 17/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

M-TAPA is a novel approach to block anterolateral thoracolumbar nerves which is relatively more convenient for application with lesser complications. But limited literature is available for its extent and duration of analgesia till date. Hence, we planned the present prospective randomized single blinded study to evaluate efficacy of M-TAPA block (applied bilaterally after induction of general anaesthesia) for providing postoperative analgesia in initial 24 hours postoperatively in patients undergoing Laparoscopic Cholecystectomy under general anaesthesia (GA).

 
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