| CTRI Number |
CTRI/2025/07/091008 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| 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
|
Comparison of two nerve block techniques for pain relief after gallbladder surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of external oblique interfascial plane block with subcostal transversus abdominis plane block 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 Jasvinder Singh |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8383981541 |
| Fax |
|
| Email |
jasvinder07gh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Government 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 Jasvinder Singh |
Vardhman Mahavir medical college and Safdarjung hospital |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New
Delhi 110029
New Delhi
DELHI |
8383981541
jasvinder07gh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Protocol Review Committee IPRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I-II patients with no known comorbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided Right sided External oblique inter-fascial plane block and Left sided Rectus sheath block |
we are trying compare External oblique inter-fascial plane block with Subcostal transversus abdominis plane block for postoperative analgesia by using cumulative opioid consumption over first 24 hour in patients undergoing laparoscopic cholecystectomy under general anaesthesia. |
| Comparator Agent |
USG guided Right sided Subcostal Tranversus Abdominis plane block and Left sided Rectus sheath block |
we are trying to compare External oblique inter-fascial plane block with Subcostal transversus abdominis plane block for postoperative analgesia by using cumulative opioid consumption over first 24 hour in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I-II scheduled for inguinal hernia surgery. |
|
| ExclusionCriteria |
| Details |
1.history of allergy or hypersensitivity to local anaesthetics
2.local site infection
3.coagulopathy
4.inability to understand pain scale (numeric rating scale)
5.bmi more than 30 kg/m2
6.pregnancy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare External oblique inter-fascial plane block with Subcostal transversus abdominis plane block for postoperative analgesia by using cumulative opioid consumption over first 24 hour in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
over first 24 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative fentanyl consumption.
2.Intraoperative hemodynamic parameters
3.Numeric rating scale at 30 min,2, 4, 8, 12 and 24 hours postoperatively.
4.Time to first rescue analgesia.
5.Patient satisfaction in terms of pain relief using Likert scale.
|
Numeric rating scale at 30 min,2, 4, 8, 12 and 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
27/07/2025 |
| 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="0"
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
|
This study aims to compare the effectiveness of two regional anaesthesia techniques that is external oblique interfascial plane block and the subcostal transversus abdominis plane block for managing postoperative pain in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Effective postoperative pain control is crucial for early recovery, patient comfort and reduced opioid consumption. in this randomized, prospective trial, patients will be allocated to receive either of the block after induction. Pain score, nausea vomiting score, sedation score, sedation score, total opioid requirement and patient satisfaction will be recorded and compared between the groups. |