| CTRI Number |
CTRI/2025/01/079146 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between external oblique intercostal plane block and erector spinae plane block in providing post operative analgesia in patients undergoing open hepatopancreatic and biliary surgeries |
|
Scientific Title of Study
|
External oblique intercostal plane block versus Erector spinae plane block for post operative analgesia in open hepatopancreatic biliary surgeries- a randomized control 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 |
Dr Kiran Premraj |
| Designation |
Senior Resident, Department of Anaesthesiology |
| Affiliation |
Institute of Liver and Biliary sciences |
| Address |
Department of Anaesthesiology, Institute of liver and biliary sciences, D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9567070594 |
| Fax |
|
| Email |
kiranpremraj1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology, Institute of liver and biliary sciences, D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Premraj |
| Designation |
Senior resident, Department of anaesthesiology |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology, Institute of liver and biliary sciences, D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9567070594 |
| Fax |
|
| Email |
kiranpremraj1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of liver and biliary sciences, Sector D1, Vasant Kunj, New Delhi , Pin- 110070, Country- India, Country code- 91 |
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
Sector D1, Vasant Kunj, New Delhi , Pin- 110070, Country- India, Country code- 91 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kiran Premraj |
Institute of liver and biliary sceinces |
Room number - 14064,Department of anaesthesiology, Institute of liver and biliary sciences, Sector D1, Vasant Kunj, New Delhi , Pin- 110070, Country- India, Country code- 91
South West
DELHI |
9567070594
kiranpremraj1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF LIVER AND BILIARY SCIENCES, VASANTKUNJ |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Plane block |
Bilateral continuous erector Spinae Plane block under ultrasound guidance given intraoperatively with a bolus of Local anaesthetic and the infusion of local anaesthetic is continued in the postoperative period for 48 hours. |
| Intervention |
External Oblique intercostal plane block |
Bilateral continuous External oblique intercostal plane block under ultrasound guidance is given intraoperatively with a bolus of Local anaesthetic and continued in the postoperative period as infusion for 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years , undergoing open hepatopancreatic and biliary surgery, who give consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at site of administration
Allergy to local anaesthetics
Insufficient comprehension of the use of Patient controlled Analgesia ( PCA) machine
Coagulopathy and thrombocytopenia (Platelet count less than 80,000/ microL )
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative fentanyl
consumption at 24 hours between the external oblique intercostal plane block and Erector spinae plane block groups |
upto 24 hours in the post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative IV fentanyl requirements in both the groups.
To compare the postoperative pain using NRS in both the groups
To compare the time of first rescue analgesia requirement in both the groups
To compare intraoperative fluid administered in both groups
To compare the rate of complications in both the groups (respiratory depression, nausea, vomiting, pruritis)
|
upto first 48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
09/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypothesis; external oblique intercostal plane block is as effective as erector spinae plane block in providing analgesia in patients undergoing open hepatopancreatic biliary surgeries
Study population - 60 patients undergoing open hepatopancreatic biliary surgeries
Group A- 30 patients- USG guided External oblique intercostal plane block. Group B- 30 patients- USG guided Erector spinae plane block. |