| CTRI Number |
CTRI/2024/11/076645 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two commonly used pain relief methods in liver donation surgery . |
|
Scientific Title of Study
|
A comparative evaluation of external oblique intercostal plane block and intrathecal morphine in patients undergoing open donor hepatectomy : 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 Manikandan G |
| Designation |
Senior Resident |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Room no 1056 ,Department of Anesthesiology ,3rd Floor , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi - 110070
South
DELHI
110070
India |
| Phone |
9791601211 |
| Fax |
|
| Email |
gurumurthymanikandan3@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 1314 ,Department of Anesthesiology ,3rd Floor , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi - 110070
South
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Room no 1314 ,Department of Anesthesiology ,3rd Floor , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi - 110070
Department of anesthesia , ilbs hospital , vasant kunj
South
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi , India , Pincode -110070 |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences Hospital |
| Address |
D-1 , Vasant Kunj , New Delhi , India , Pincode -110070 |
| 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 Manikandan G |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
Room no 1056 , Department of Anesthesia , 3rd Floor ,D-1 , Vasant Kunj , New Delhi , India , Pincode -110070
South
DELHI |
9791601211
gurumurthymanikandan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute of liver and biliary sciences hospital , vasant kunj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
prospective living related liver donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Oblique Intercostal Plane Block |
External oblique intercostal plane block will be performed under ultrasound guidance bilaterally ,bolus dose of local anesthetic will be injected , a catheter will be placed in the space created followed by continuous infusion of local anesthetic drug and analgesia will be monitored for 48 hours |
| Comparator Agent |
Intrathecal Morphine |
Preservative free morphine 300 micrograms will be given intrathecally between the L3 and L4 space in the lumbar spine and analgesia will be monitored for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age – 18 to 60 years undergoing open living donor hepatectomy. Patients giving consent
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindication to neuraxial anaesthesia Allergy to local anesthetics
Allergy to morphine
Insufficient comprehension to use of PCA
|
|
|
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 and intrathecal morphine groups |
upto first 24h in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative pain (both static and dynamic ) using NRS score in between the two groups
To compare the time of first rescue analgesia requirement in both the groups
To compare the incidence of shoulder pain between the two groups
To compare the rate of complications in both the groups( hypotension , bleeding , bradycardia , respiratory depression, nausea, vomiting, etc )
|
upto first 48h after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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 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
|
Postoperative pain is an important cause of morbidity in voluntary healthy individuals undergoing donor hepatectomy.
A single shot of Intrathecal Morphine is a simple, effective and easily performed neuraxial technique with low technical failure rate .
Ultrasound guided External Oblique intercostal Plane block is an emerging technique and is easy to perform , reliable and an alternate to Intrathecal Morphine . In this study , we aim to compare the Ultrasound Guided External Oblique Intercostal Block and Intrathecal Morphine for pain management in donor hepatectomy surgery .
|