| CTRI Number |
CTRI/2025/07/090822 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To look for effectiveness of 2 different types of block for pain control after kidney surgery |
|
Scientific Title of Study
|
External oblique intercostal block with Rectus sheath block versus erector spinae plane block for post operative analgesia following nephrectomy-A randomised controlled comparative non-inferiority trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Kumari |
| Designation |
Academic Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology IGIMS Patna 800014 Bihar
Department of Anaesthesiology IGIMS patna 800014 Bihar
Patna
BIHAR
800014
India |
| Phone |
9123400970 |
| Fax |
|
| Email |
golden.riya16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Arun |
| Designation |
Additional professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology IGIMS Patna 800014 Bihar
Department of Anaesthesiology IGIMS Patna 800014 Bihar
Patna
BIHAR
800014
India |
| Phone |
9523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Kumari |
| Designation |
Academic Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology IGIMS Patna-800014 Bihar
Department of Anaesthesiology IGIMS Patna-800014 Bihar
Patna
BIHAR
800014
India |
| Phone |
9123400970 |
| Fax |
|
| Email |
golden.riya16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences Patna Bihar 800014 India |
|
|
Primary Sponsor
|
| Name |
Dr Riya Kumari |
| Address |
Department of Anaesthesiology IGIMS Patna-800014 Bihar |
| Type of Sponsor |
Other [Self] |
|
|
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 Riya Kumari |
IGIMS |
Ward block ,first floor,Department of Anaesthesiology Patna 800014
Patna
BIHAR |
9123400970
golden.riya16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee ,IGIMS patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (2) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Postoperative analgesia |
One group will receive External Oblique lntercostal Block with rectus sheath block using 0.25 percentage of bupivacaine combined with dexmedetomidine for post operative analgesia following nephrectomy in patients |
| Intervention |
Postoperative analgesia |
The other group will receive Erector Spinae Plane Block using 0.25 percent of bupivacaine combined with dexmedetomidine for post-operative analgesia following nephrectomy in patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Posted for elective nephrectomy under general anesthesia
American society of anesthesiologists (ASA)status 1 or 2
|
|
| ExclusionCriteria |
| Details |
Patients refusal
Pregnancy
Patients with allergy to Local anesthesia
BMI greater than 30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic efficacy of 2 different regional anesthesia techniques using median pain score during first 24 hours postoperatively |
Post operative 1hr 2hr 4hr 8hr 12hr 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1st request for post-operative analgesia
Total morphine consumption
Patients satisfaction score
Adverse effects |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
20/08/2025 |
| 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 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
|
This study aims to compare two types of nerve blocks—external oblique intercostal with rectus sheath block (EOI + RSB) and erector spinae plane block (ESP)—for pain relief after kidney removal surgery (nephrectomy). Both techniques are designed to reduce the need for opioids and their side effects while improving recovery. The study involves 98 patients, who will receive either block after surgery, and their pain levels, time until first pain medication, total morphine use, side effects, and satisfaction will be monitored for 24 hours. The goal is to see if the EOI + RSB combination provides pain relief that is as good as the ESP block, offering another safe and effective option for postoperative care. |