| CTRI Number |
CTRI/2025/07/090995 [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 Trial |
|
Public Title of Study
|
Patient who will be Undergoing Donor Hepatectomy Surgery and will be participating in the study, for their pain management either External Oblique Intercoastal Plane Block or Erector Spinae Plane Block will be given. |
|
Scientific Title of Study
|
External Oblique Intercoastal Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Donor Hepatectomy Patients- 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 |
Savita Agarwal |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9992900553 |
| Fax |
|
| Email |
saavijangra553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Sindwani |
| Designation |
Additional Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita Agarwal |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9992900553 |
| Fax |
|
| Email |
saavijangra553@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences, New Delhi, India, 110070 |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi, India, 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 Savita Agarwal |
Institute of Liver and Biliary Sciences, |
Department of Anaesthesia and Critical Care, Phase 2, Academic Cell, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi, India, 110070
New Delhi
DELHI |
9992900553
saavijangra553@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituonal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z526||Liver donor, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound Erector Spinae plane block |
After induction of anaesthesia, ultrasound Erector Spinae plane block will be given bilaterally. Bolus of 0.25% of levobupivacaine will given, followed by insertion of epidural catheters. Intraoperatively, infusion of 0.125% levobupivacaine with 0.5 microgram/kg of dexmedetomidine will be given. postoperatively, infusion of 0.125 of levobupivacaine will be given till 48 hours. Rescue analgesia with intravenous fentanyl will be given via PCA pump. will be given.
|
| Intervention |
Ultrasound External oblique plane block |
After induction of anaesthesia, ultrasound External oblique plane block will be given bilaterally. Bolus of 0.25% of levobupivacaine will given, followed by insertion of epidural catheters. Intraoperatively, infusion of 0.125% levobupivacaine with 0.5 microgram/kg of dexmedetomidine will be given. postoperatively, infusion of 0.125 of levobupivacaine will be given till 48 hours. Rescue analgesia with intravenous fentanyl will be given via PCA pump. will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 & 2 patients undergoing donor hepatectomy surgery
2. Donor hepatectomy surgery |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection at site of administration
3. Allergy to local anaesthetics
4. Insufficient comprehension to use of PCA
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total amount of postoperative rescue analgesia (IV fentanyl) requirement during first 24hrs in External Oblique Intercoastal block and Erector Spinae Plane block groups
|
at 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the intraoperative IV fentanyl requirements in both the groups
2. To compare the time of first rescue analgesia requirement in both the groups
3. To compare the IV fentanyl requirements at 48 hours in both the groups
4. To compare the time taken for procedure in both the groups
5. To compare the postoperative pain using NRS in both the groups
6. To compare the intraoperative fluid administered in both the groups.
7. To compare the rate of complications in both the groups |
1. Fentanyl consumption 48 hours
2. Numerical rating scale at Extubation, at 1hr, 2hr, 3hr, 4hr, 5hr, 6hr, 12hr, 24hr, 36hr, 48hr. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
26/07/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ultrasound guided External Oblique intercoastal Plane block is a emerging technique, which blocks anterior and lateral cutaneous branches of thoracoabdominal nerves and has been successful in upper abdominal surgeries for perioperative pain management. Erector spinae plane block have been in practice for some time for thoracic surgeries and major abdominal surgeries. As there is no literature comparing both the blocks in donor hepatectomy surgeries, this study will compare both the blocks for perioperative analgesia in patient undergoing donor hepatectomy surgeries. |