| 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
|
|
|
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
|
|
|
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. |