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CTRI Number  CTRI/2026/01/100102 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing two ultrasound guided abdominal nerve blocks for pain relief after laparoscopic gallbladder surgery 
Scientific Title of Study   Preemptive Deep rectus Sheath block vs Subcostal transversus abdominis plane block for postoperative pain relief in Laparoscopic Cholecystectomy: A randomized double blinded trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudharsan R 
Designation  Postgraduate  
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute, Pondicherry Cuddalore ECR Road, Pillayarkuppam, Puducherry – 607402.

Pondicherry
PONDICHERRY
607402
India 
Phone  8883243865  
Fax    
Email  sudharsan.sudhu10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gayatri Mishra  
Designation  Professor  
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry Cuddalore ECR Road, Pillayarkuppam, Puducherry – 607402.

Pondicherry
PONDICHERRY
607402
India 
Phone  9894354068  
Fax    
Email  drgayatrimishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gayatri Mishra  
Designation  Professor  
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry Cuddalore ECR Road, Pillayarkuppam, Puducherry – 607402.

Pondicherry
PONDICHERRY
607402
India 
Phone  8883243865  
Fax    
Email  drgayatrimishra@gmail.com  
 
Source of Monetary or Material Support  
Mahatma gandhi medical college and research institute Pondicherry Cuddalore East Coast Road Pillayarkuppam Puducherry india 607402 
 
Primary Sponsor  
Name  Mahatma gandhi medical college and research Institute 
Address  Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore ECR Road Pillayarkuppam Puducherry 607402. 
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 Gayatri Mishra  Mahatma Gandhi Medical College and Research Institute  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pondicherry Cuddalore East Coast Road Pillayarkuppam Puducherry 607402
Pondicherry
PONDICHERRY 
9894354068

drgayatrimishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SBV Institutional Human Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided Deep Rectus Sheath Block   After induction of general anaesthesia, under aseptic precautions and ultrasound guidance, a linear high frequency probe between four and fifteen megahertz will be placed transversely between the xiphisternum and the umbilicus. Using an in plane technique, a twenty five gauge Quincke needle will be advanced to the pre peritoneal space beneath the posterior rectus sheath on each side. After confirming the correct plane by hydrodissection, 20 ml of 0.25% bupivacaine will be injected bilaterally. 
Comparator Agent  Ultrasound guided Subcostal Transversus Abdominis Plane Block   After induction of general anaesthesia, under aseptic precautions and ultrasound guidance, a linear high frequency probe between fifteen and twenty megahertz will be placed just below the costal margin along the mid clavicular line. Using an in plane technique, a twenty five gauge Quincke needle will be advanced between the internal oblique and transversus abdominis muscle layers. After confirming correct needle placement by hydrodissection, 20ml of 0.25% bupivacaine will be injected bilaterally. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Physical Status I, II, or III.

Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
Patients willing to provide written informed consent for participation in the study. 
 
ExclusionCriteria 
Details  a)Known allergy or hypersensitivity to local anaesthetic agents.

b)Seizure disorder or other neurological conditions contraindicating local anaesthetics.

c)Previous upper abdominal midline scar or surgery altering anatomy at block site.

d)Coagulopathy or patients on anticoagulant therapy.

e)Body weight less than 45 kg.

f)Conversion to open cholecystectomy during surgery. 
 
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 
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) at predetermined time intervals (0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively).  From immediate postoperative period (0 hour) up to 24 hours postoperatively at predetermined time intervals (0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively). 
 
Secondary Outcome  
Outcome  TimePoints 
1)Time to first rescue analgesic requirement after surgery (in hours).

2)Total postoperative tramadol requirement within 24 hours.

3)Total intraoperative fentanyl requirement (in micrograms).

4)Hemodynamic response to pneumoperitoneum – Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) recorded every 15 minutes intraoperatively.

5)Total procedure time (sum of ultrasound scanning and needling time in minutes). 
Intraoperative and up to 24 hours postoperatively. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   12/01/2026 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is a common procedure for gallbladder disease but patients often experience moderate postoperative pain that may delay recovery. Regional anaesthesia techniques such as the subcostal transversus abdominis plane block and the newer deep rectus sheath block have shown potential for improving postoperative analgesia.
This prospective randomized double blinded active controlled interventional study aims to compare the analgesic efficacy of pre-emptive ultrasound guided deep rectus sheath block versus subcostal transversus abdominis plane block in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.

Fifty six ASA I to III patients aged 18 to 70 years will be randomized into two equal groups of twenty eight each. After induction of general anaesthesia Group 1 will receive a bilateral ultrasound guided deep rectus sheath block with  20 mL of 0.25 percent percent bupivacaine on each side in the pre peritoneal space. Group 2 will receive a bilateral ultrasound guided subcostal transversus abdominis plane block with 20 mL of 0.25 percent bupivacaine deposited between the internal oblique and transversus abdominis muscles.

The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale at rest at predetermined intervals two hourly for the first eight hours and four hourly up to twenty four hours. Secondary outcomes include time to first rescue analgesic, total tramadol and fentanyl requirements, intraoperative hemodynamic changes during pneumoperitoneum, and total procedure time. Data will be analyzed using appropriate statistical tests with a p value less than 0 point 05 considered significant.

 
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