| CTRI Number |
CTRI/2025/09/095506 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of nerve blocks to reduce pain after renal surgeries. |
|
Scientific Title of Study
|
A study to compare and evaluate the analgesic efficacy of erector spinae block and anterior quadratus lumborum block using levobupivacaine in renal surgeries. |
| 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 Anurag Narwal |
| Designation |
Post Graduate Resident |
| Affiliation |
School of medical sciences and research |
| Address |
Department of anaesthesia school of medical sciences and research Sharda University
Knowledge park 3 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8708414564 |
| Fax |
|
| Email |
anuragnarwal15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of anaesthesia school of medical sciences and research Sharda University
Knowledge park 3 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
Shiv.singh@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Kumar |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of anaesthesia school of medical sciences and research Sharda University
Knowledge park 3 greater noida
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
Shiv.singh@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology school of medical sciences and research Sharda University Greater Noida Gautam Buddha Nagar Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research |
| Address |
Department of anaesthesia school of medical sciences and research Sharda University Knowledge park 3 greater noida Gautam Buddha Nagar 201306 Uttar Pradesh |
| 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 Shiv Kumar |
School of Medical Sciences and Research Sharda Hospital |
Block 2F Department of anaesthesia school of medical sciences and research Sharda University knowledge park 3 greater noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH |
9650943359
Shiv.singh@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Sciences and Research Sharda Hospital |
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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anterior Quadratus lumborum Block |
Block Q- Patients will receive a local anaesthetic of 25ml 0.25% levobupivacaine 25 min before surgery.These patients will receive ultrasound guided Anterior Quadatus Lumborum Block. |
| Intervention |
Erector Spinae Plane Block |
Group E -patient will receive a local anaesthetic of 25ml 0.25% of injection levobupivacaine 25 min before surgery. These patients will receive ultrasound guided Erector Spinae Plane nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 to 3
Both Gender
Elective Renal Surgeries under General Anaesthesia
Age 18 to 60
Patients able to understand and rate their pain according to visual Analouge Scale
Patient giving consent for block
|
|
| ExclusionCriteria |
| Details |
Pregnant females
Patients having history of drug allergy to levobupivacaine
Patient having history of significiant respiratory or cardiovascular or hepatic or endocrine and psychiatry disease
Patient not giving consent for performing block
BMI more than 35 per metre square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of erector spinae plane block and anterior quadratus lumborum block using levobupivacaine in renal surgeries |
24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the timing of first rescue analgesia and total requirement of rescue analgesia
To measure incidence of complications such as
Hematoma
Vomiting
Hypotension |
|
Time of requirement for first rescue analgesia in post operative period.
Total amount of rescue analgesia consumed in first 24 hours
To measure incidence of complications such as
Hematoma
Vomiting
Hypotension
|
24 hours post operative peroid |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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 prospective, randomized, double-blinded, controlled clinical study aims to compare and evaluate the analgesic efficacy of erector spinae plane block (ESPB) and anterior quadratus lumborum block (QLB) using 0.25% levobupivacaine in patients undergoing elective renal surgeries under general anaesthesia. A total of 50 patients (ASA I–III, aged 18–60 years) will be randomly allocated into two groups: Group E will receive ultrasound-guided ESPB with 25 ml of 0.25% levobupivacaine, and Group Q will receive ultrasound-guided QLB3 with 25 ml of 0.25% levobupivacaine.
The primary objective is to compare the postoperative analgesic efficacy of ESPB and QLB using Visual Analogue Scale (VAS) scores. Secondary objectives include evaluating the time to first rescue analgesia, total analgesic requirement in the first 24 hours, and incidence of complications such as nausea, vomiting, hypotension, and hematoma.
The study will be conducted in the Department of Anaesthesiology, School of Medical Sciences & Research, Sharda University, Greater Noida, over a period of 18 months (May 2025 – November 2026). Data will be statistically analysed using SPSS v25.0, with a p-value <0.05 considered significant. |