| CTRI Number |
CTRI/2024/05/067658 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| 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 pain relief methods for liver donation surgery |
|
Scientific Title of Study
|
External Oblique Intercostal Nerve Block versus Epidural in Live Open Donor Hepatectomy- A Randomised Controlled 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 Rachana C Nair |
| Designation |
Senior resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room no 1056 ,Institute of Liver and Biliary Sciences
Department of Anesthesiology
D-1, Vasant Kunj
New Delhi, India
South
DELHI
110070
India |
| Phone |
9400465302 |
| Fax |
|
| Email |
rachanacnair89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room no 1056 Institute of Liver and Biliary Sciences
D-1, Vasant Kunj
New Delhi, India
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana C Nair |
| Designation |
Senior resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room no 1056 Institute of Liver and Biliary Sciences
Department of Anesthesiology
D-1, Vasant Kunj
New Delhi, India
DELHI
110070
India |
| Phone |
9400465302 |
| Fax |
|
| Email |
rachanacnair89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences
Vasant Kunj
Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
Dr Rachana C Nair |
| Address |
Senior Resident
Room no 1056
Department of Anesthesiology
Institute of Liver and Biliary Sciences
Institute of Liver and Biliary Sciences
Vasant Kunj - Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gaurav Sindwani |
Associate Professor
Room no1314
Institute of Liver and Biliary Sciences
Vasant Kunj
Delhi
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachana C Nair |
Room no-1056 Institute of Liver and Biliary Sciences |
Institute of Liver and Biliary Sciences
Vasant Kunj
Delhi
110070
South
DELHI |
9400465302
rachanacnair89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Institute of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural block |
Thoracic epidural will be inserted. Bolus and continuous infusion of drugs will be given for a period of 48 hrs |
| Intervention |
External Oblique intercostal block |
External oblique block will be put bilaterally,catheter will be placed in space bolus and infusion dose of drugs will be given for a period of 48 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 18 - 60 years, undergoing open live donor hepatectomy |
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindication to neuraxial anesthesia
Allergy to local anesthetics
Insufficient comprehension to use of IVPCA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative fentanyl consumption at 48 hours between the two groups. |
To compare postoperative fentanyl consumption at 48 hours between the two groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative IV fentanyl requirements in both groups
To compare the time of first rescue analgesia requirement in both the groups
To compare the postoperative pain using NRS in both the groups
To compare the intraoperative fluid requirements in both the groups
To compare the rate of complications in both the groups |
Baseline, intraoperative at 15 minutes interval, postoperative till 48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
03/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Living donor liver transplantation is a definitive treatment for end stage liver disease patients. Postoperative pain is an important cause of morbidity in the donor population. Pain in donor hepatectomy is multifactorial due to large subcostal incision, rib retraction, diaphragmatic irritation or of visceral origin.This can have a significant negative impact on the quality of life of the donor. There are various modalities for pain treatment in donors. Epidural is the standard of care. Thoracic epidural analgesia provides efficient intraoperative and postoperative analgesia following donor hepatectomy. The effectiveness of the block has been shown in many literatures and is considered relatively safe to perform, as compared to other regional technique.However due to concerns of postoperative coagulopathy, the procedure has concerns. USG guided abdominal wall blocks are generally easy to apply, reliable and are alternatives to epidural analgesia.They can be easily performed with the patient in the supine position. US guided External Oblique Intercostal block is an emerging technique, which blocks anterior and lateral cutaneous branches of the thoracoabdominal nerves and has been used successfully in upper abdominal surgeries for perioperative analgesia. Till now there are no studies in EOI block in patients undergoing hepatectomy. In this study we aim to compare ultrasound guided continuous bilateral EOI block and continuous thoracic epidural analgesia for pain management in donor hepatectomy |