| CTRI Number |
CTRI/2025/10/096655 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Types of Abdominal Nerve Blocks to Manage Pain After Keyhole Kidney Surgery |
|
Scientific Title of Study
|
Comparison of External Oblique Rectus Abdominis Plane block with Transversus Abdominis Plane block for post operative Analgesia in patients undergoing Laparoscopic Renal surgery |
| 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 Komal Mishra |
| Designation |
PG resident |
| Affiliation |
Vardhman Mahavir medical College and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care,VMMC and Safdarjung hospital,Ansari nagar east,New Delhi
South
DELHI
110029
India |
| Phone |
9582244613 |
| Fax |
|
| Email |
mishralucky96.km@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical College and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care,VMMC and Safdarjung hospital,Ansari nagar East,New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Guria |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical College and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care,VMMC and Safdarjung hospital,Ansari nagar East,New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital New Delhi
PIN code 110029
INDIA
PIN code 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Ansari nagar east ,New delhi
PIN code 110029
INDIA |
| Type of Sponsor |
Government 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 Komal Mishra |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and intensive care Ansari nagar East Delhi 110029 New Delhi DELHI
South
DELHI |
9582244613
mishralucky96.km@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N258||Other disorders resulting from impaired renal tubular function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
25ml O.25%Levobupivacaine + 4mg Dexamethasone |
25ml 0.25% Levobupivacaine +4mg Dexamethasone will be given under USG guidance for comparing External oblique-Rectus Abdominis plane block and Transversus Abdominis plane block after induction of anaesthesia |
| Intervention |
25ml of 0.25%Levobupivacaine +4mg Dexamethasone |
25ml 0.25% Levobupivacaine +4mg Dexamethasone will be given under USG guidance for comparing External oblique-Rectus Abdominis plane block and Transversus Abdominis plane block after induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients undergoing laparoscopic Renal surgery |
|
| ExclusionCriteria |
| Details |
1.Patients with known case of coagulopathy or on anticoagulant therapy
2.Infection at the proposed site of block
known allergies to effect of local anaesthetics
3.BMI greater than 30 Kg per meter square
4.Pregnancy
5.Inability to understand pain scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare External oblique-Rectus Abdominis plane block with Transversus Abdominis plane block for
postoperative analgesia in patients undergoing laparoscopic renal surgery using Numeric Rating Scale
|
Numeric Rating Scale at 6hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare External Oblique Rectus Abdominis plane block with Transversus Abdominis plane block for postoperative analgesia in patients undergoing laparoscopic renal surgery with regards to-
1.Numerical Rating Scale pain scores at half hour,2nd hour,4th hour,12th hour,24th hour
2.Total fentanyl requirements during intraoperative period.
3.Time taken to first rescue analgesia demand.
4.Total Tramadol consumption during first 24 hours of postoperative period.
5.To assess Quality of recovery score -15 |
Numeric rating scale at 0.5,2,4,6,12 & 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="1"
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
|
Effective postoperative analgesia is crucial for patients undergoing laparoscopic renal surgery to facilitate early mobilization, reduce opioid consumption, and improve overall recovery. The transversus abdominis plane (TAP) block is a well-established regional anesthesia technique that provides somatic pain relief from the anterior abdominal wall. However, the TAP block may provide limited coverage for upper abdominal incisions commonly used in renal surgeries. The external oblique–rectus abdominis plane (EO-RAP) block is a newer regional analgesic technique that targets the interfascial plane between the external oblique and rectus abdominis muscles, potentially providing broader and more effective analgesia for upper abdominal and subcostal regions. This study aims to compare the efficacy and safety of the EO-RAP block versus the conventional TAP block in providing postoperative analgesia for patients undergoing laparoscopic renal surgery. The primary objective is to assess postoperative pain scores, while secondary objectives include evaluating opioid consumption, duration of analgesia, and incidence of block-related complications. |