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CTRI Number  CTRI/2024/11/076748 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two nerve blocks for decreasing pain after surgery in patients having gallbladder removal surgery. 
Scientific Title of Study   Comparison of efficacy of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs Oblique subcostal transverse abdominis plane block (OSTAP) 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 Jatin Lal 
Designation  Professor 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Dept. of Anaesthesiology, 2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9728265511  
Fax    
Email  dr.jatinlal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jatin Lal 
Designation  Professor 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Dept. of Anaesthesiology, 2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9728265511  
Fax    
Email  dr.jatinlal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aashi Mishra 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Dept. of Anaesthesiology, 2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  7906542800  
Fax    
Email  ashimishra97@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesiology & Critical Care, Pt. B. D. Sharma PGIMS, Rohtak-124001, Haryana (India).  
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS 
Address  Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana  
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 
Dr Jatin Lal  Pt. B. D. Sharma PGIMS, Rohtak.  Dept. of Anaesthesiology & Critical Care, 2nd Floor, Modular OT Complex Rohtak Rohtak
Rohtak
HARYANA 
9728265511

dr.jatinlal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)   After tracheal intubation, a high-frequency linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 20 ml 0.25% bupivacaine will be injected between the transversus abdominis muscle and the lower aspect of the costal cartilage. The same procedure will be repeated on the contralateral side. 
Comparator Agent  Oblique subcostal transverse abdominis plane block (OSTAP)  The patients will receive OSTAP block in the supine position immediately after the endotracheal intubation.The ultrasound with a linear probe will be placed along the subcostal margin of the upper abdominal wall and obliquely from the xiphoid to the right iliac crest in the midabdominal line. Rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin. The needle will be directed to the transversus abdominis fascia. 20 ml 0.25% bupivacaine will be injected between rectus abdominis and transversus abdominis muscles along the oblique subcostal line. The same procedure will repeated for the contralateral side. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age between 18-65 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery under general anaesthesia will be included in the study. 
 
ExclusionCriteria 
Details  - Refusal of consent
- Coagulation disorder.
- Infection at the injection site of the block.
- Known allergy to local anaesthetics.
- Chronic hepatic or renal failure.
- History of abdominal surgery or trauma.
- Conversion of laparoscopic to open surgery.
- Consumption of any pain killers within the 24 h before the operation.
- Chronic opioid consumption.
- Pregnancy.
- Alcohol or drug abuse.
- Body mass index (BMI) ≥ 35 kg m-2. 
 
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 
Compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption.  Postoperative 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain evaluation using Numeric Rating Scale (NRS)   0min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively. 
Time to first rescue analgesic  Postoperative 24 hrs 
Anesthetized thoracoabdominal dermatomes at 2 hours after surgery  Postoperative 2 hrs 
Adverse events  Postoperative 24 hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 prospective randomised study will be conducted in 50 patients aged 18-65 years, either gender, ASA I-II undergoing elective laparoscopic cholecystectomy after obtaining institutional ethics committee approval,  CTRI registration and patients written informed consent. Patient refusal of consent, coagulation disorder, infection at the injection site of the block, known allergy to local anaesthetics, chronic hepatic or renal failure, history of abdominal surgery or trauma, conversion of laparoscopic to open surgery, consumption of any pain killers within the 24 h before the operation, chronic opioid consumption, pregnancy, alcohol or drug abuse and body mass index (BMI) ≥ 35 kg m-2will be excluded. The aim of the study is to compare the efficacy of MTAPA with OSTAP block for postoperative pain relief. The primary objective is to compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption in the first 24 hours. The secondary objectives are to assess postoperative pain evaluation using Numeric Rating Scale (NRS) at 0 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively and at the time of rescue analgesic request, time to first rescue analgesic administration, number of thoracoabdominal dermatomes anaesthetised at 2 hrs after surgery and Adverse effects (if any). Patients will be randomized into 2 groups : Group O and Group M. Group O will be given OSTAP block bilaterally after induction of anaesthesia. Group M will be given MTAPA block bilaterally after induction of anaesthesia. Demographic data, evaluation of pain using NRS scale, time to first rescue analgesic, total rescue analgesic consumption, number of thoracoabdominal dermatomes anaesthetized and adverse effect, if any will be observed.

 
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