FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090427 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 07/01/2026
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 compare the efficacy of ultrsaound guided erector spinae plane block versus quadratous lumborum block for post operative analgesia in patients undergoing percutaneous nephrolithotomy surgery. 
Scientific Title of Study   Efficacy of ultrasound guided erector spinae block in comparison to quadratous lumborum block for post operative analgesia in patients undergoing percutaneous nephrolithotomy surgery: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  DR PRIYANSHU 
Designation  Junior Resident 
Affiliation  Department of Anaesthesia Government Institute of Medical Sciences Greater Noida,U.P. 
Address  Department of Anaesthesia Government Institute of Medical Sciences Greater Noida,U.P.
Gautam Buddha University, Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  8299732347  
Fax    
Email  palpriyanshu21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SAVITA GUPTA 
Designation  Associate professor 
Affiliation  GOVERNMENT INSTITUTE OF MEDICAL SCIENCES GREATER NOIDA,U.P. 
Address  Department of Anaesthesia GOVERNMENT INSTITUTE OF MEDICAL SCIENCES GREATER NOIDA,U.P.
Gautam Buddha University, Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  8750657382  
Fax    
Email  dr.gsavita@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PRIYANSHU 
Designation  JUNIOR RESIDENT 
Affiliation  Government Institute of Medical Sciences Greater Noida, U.P. 
Address  Department of Anaesthesia Government Institute of Medical Sciences Greater Noida, U.P.
Gautam Buddha University, Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  8299732347  
Fax    
Email  palpriyanshu21@gmail.com  
 
Source of Monetary or Material Support  
Government Institute of Medical Sciences Kasna Greater Noida, U.P. PINCODE-201312, INDIA 
 
Primary Sponsor  
Name  Government Institute of Medical Sciences 
Address  Government Institute of Medical Sciences Kasna Greater Noida,U.P. PINCODE-201312, INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanshu   Government Institute of Medical Sciences   Department of Anaesthesia, Government Institute of Medical Sciences (GIMS)
Gautam Buddha Nagar
UTTAR PRADESH 
08750657382

palpriyanshu21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Errector spinae block  After all aseptic precautions, 2 ml of 2% lidocaine infiltration will be given subcutaneously at the site where the block will be given. Under ultrasound guidance, a 90 mm 22 gauge spinal needle will be inserted in a cranial to caudal direction by the in- plane needling technique, aiming at the tip of the transverse process. 20 ml of Ropivacaine 0.2% will be injected after making mild contact with the transverse process tip. 
Intervention  Quadratus Lumborum Block  A 22-gauge, 90 mm spinal needle will be inserted in plane relative to the ultrasound probe passing in posterior to anterior direction through the QL muscle to reach the border between the QL and psoas major muscle. After confirmation of negative blood aspiration, 20 ml of Ropivacaine 0.2% will be injected. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled for unilateral elective
PCNL surgery classified as American Society of
Anaesthesiologists (ASA) physical status I, II & III. 
 
ExclusionCriteria 
Details  Patients with contraindications to regional anesthesia (coagulopathy or bleeding
disorder, local infection at the proposed block site) or Known allergy to local anaesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare duration of postoperative analgesia provided by Errector spinae block and quadratus lumborum block  To compare duration of postoperative analgesia provided by Errector spinae block and quadratus lumborum block 
 
Secondary Outcome  
Outcome  TimePoints 
To assess total tramadol consumption and block related complications in 24 hours.  1,2.3.4,8,12,24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2025 
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)
Modification(s)  
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  
INTRODUCTION Pain management following percutaneous nephrolithotomy (PCNL) remains a critical aspect of postoperative care, as inadequate analgesia can lead to increased morbidity,
delayed recovery, and prolonged hospital stay. To address these concerns, regional anesthesia techniques, particularly ultrasound-guided blocks, have gained popularity due to their efficacy in providing targeted analgesia while minimizing systemic complications. Among the emerging regional anesthesia
techniques, the Erector Spinae Plane (ESP) Block and the Anterior Quadratus Lumborum (AQL) Block have been increasingly utilized for managing postoperative
pain following abdominal and urological surgeries. Both blocks have shown promising results in various surgical settings; however, comparative data on their
efficacy in PCNL surgery remain limited. While both blocks have shown efficacy individually in various surgical settings, there
remains limited evidence directly comparing their analgesic effectiveness in patients undergoing PCNL. This randomized prospective study aims to evaluate and compare the
efficacy, safety, and opioid-sparing effects of ultrasound-guided ESP block versus anterior QL block for postoperative pain management in PCNL.

NEED AND JUSTIFICATION OF THE STUDY Percutaneous nephrolithotomy (PCNL) is associated with significant postoperative pain
due to the nature of renal access and tract dilation. Effective pain management is crucial to enhance patient recovery, reduce opioid consumption, and minimize complications.
Regional anesthesia techniques like the Erector Spinae Plane (ESP) block and the Anterior Quadratus Lumborum block have emerged as promising options for
postoperative analgesia.Ultrasound-guided ESP and QL blocks both target different fascial planes and neural pathways, with potential variations in analgesic efficacy, duration, and side effect
profiles. However, limited comparative data exists on their relative effectiveness specifically in PCNL procedures. This randomized prospective study aims to evaluate
and compare the efficacy of these two blocks, contributing to optimized pain management strategies in urological surgeries.

NEED OF THE STUDY  As Conventional analgesic approaches like systemic opioids have limitations such as
nausea, sedation, hypotension and delayed mobilization.This study uses Ultrasound-guided Erector Spinae block (ESP) and Anterior Quadratus Lumborum(AQL) blocks which are emerging regional anesthesia techniques offering
effective, opioid-sparing analgesia with a favourable safety profile.

PRIMARY OBJECTIVE To compare the duration of post operative analgesia provided by ESP Block and AQL Block.

SECONDARY OBJECTIVETo assess total tramadol consumption in the postoperative period in first 24 hrs.
, To evaluate hemodynamic stability and incidence of block-related complications in both groups, To assess overall patient satisfaction using 5 point Likert scale.


METHODOLOGY RESEARCH DESIGN A Randomized Prospective Study

TARGET POPULATION This randomized prospective study will be conducted on patients aged between 18 and 65 years belonging to ASA classes I & III scheduled for
elective unilateral percutaneous nephrolithotomy surgery.


SAMPLE SIZE CALCULATION To compensate for the 10% dropouts we have taken total sample size of 60 (30 in each group)


PROCEDURE Preoperative assessment will be conducted on the day before surgery, during which a
thorough history and clinical examination will be done and recorded. In the operating
room, non-invasive blood pressure, oxygen saturation and electrocardiography will be
monitored, and the baseline vitals will be noted. Peripheral venous access will be
established with a 20 gauge IV cannula.

ESP group- After all aseptic precautions, 2 ml of 2% lidocaine infiltration will be given
subcutaneously at the site where the block will be given. Under ultrasound guidance, a
90 mm 22 gauge spinal needle will be inserted in a cranial to caudal direction by the in-
plane needling technique, aiming at the tip of the transverse process. 20 ml of
Ropivacaine 0.2% will be injected after making mild contact with the transverse process
tip.
QL group- The patient will be placed in the lateral decubitus position according to the
selected site of surgical intervention. The low-frequency convex probe of ultrasound will
be positioned horizontally in the anterior axillary line halfway between the subcostal
margin and iliac crest to locate the triple abdominal muscle layers, then the probe will be
relocated subsequently to the posterior axillary line until the quadratus lumborum
muscle can be visualized with its attachment to the lateral edge of the transverse process
of the L4 vertebral body, With the psoas major muscle places anteriorly, the erector
spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of
the transverse process, this is a well-recognizable pattern of a shamrock with three
leaves. A 22-gauge, 90 mm spinal needle will be inserted in plane relative to the
ultrasound probe passing in posterior to anterior direction through the QL muscle to
reach the border between the QL and psoas major muscle. After confirmation of
negative blood aspiration, 20 ml of Ropivacaine will be injected.
After giving the block, with proper aseptic measures; spinal anaesthesia (with injection
bupivacaine 0.5% 3.0 ml) with a fixed adjuvant (injection fentanyl 10 microg) for all the
patients will be administered in the sitting position.
 
Close