| CTRI Number |
CTRI/2025/04/085678 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief after liver donor surgery comparing 2 methods of pain management. |
|
Scientific Title of Study
|
Comparison of postoperative analgesia with continuous bilateral erector spinae block versus single dose intrathecal morphine in patients undergoing robotic donor hepatectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
ower 6 Floor 1 AIMS Kochi 682041
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1 AIMS Kochi 682041
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreekanth Balagopal |
| Designation |
Fellow Transplant Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
Amrita Institute of Medical Sciences Kochi
Ernakulam
KERALA
682041
India |
| Phone |
7975936468 |
| Fax |
914842852020 |
| Email |
drsreekanthbalagopal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Edapally
Kochi
682041 |
| 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 Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
Kochi 682041
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS Ethics Committee |
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 |
| Intervention |
Bilateral ESP catheters at T7 placed after anaesthesia |
20 ml of 0.2% ropivacaine with 2 mg dexamethasone on each side after intubation
Repeated 8th hourly |
| Comparator Agent |
Intrathecal morphine at 0.2 mcg/kg not exceeding 200 mcg |
Single dose of intra-thecal morphine 2 mcg/kg not exceeding 200 mcg given at L3-4 space with 25 G spinal needle before anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II volunatry donors for right lobe liver donation by robotic surgery |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Any contraindication for ESP Block or thoracic epidural
3.Allergic to local anaesthetics
4.BMI more 30
5.Previous spine surgeries or spine deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative analgesic requirement |
Time taken for surgery in hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative HR and MAP at specified time points
2. Post-operative analgesic consumption in 24 h
3. NRS and OPS 6th hrly in the ICU
4. HR and MAP 6th hrly in ICU
|
Intra-op time points
1. T0 Port Insertion
2. T10 10 minutes after pnuemoperitoneum
3. Tpf Pfannenstiel incision
4. Tg Graft retrieval
5. Tc Closure
6. Te end of surgery
Post-op time points
1. At shifting to ICU
2. T6, T 12, T 18 and T24 h
3. T IC Incentive spirometry
4. T a Ambulation
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| 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="0"
Months="6"
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
|
Central neuraxial blockade with opioid is a very simple intervention for pain management. We sought to evaluate if an intrathecal injection of opioid produced superior or comparable results to bilateral erector spiane plane blocks with catheters in robotic donor hepatectomy. |