FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094311 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of Ultrasound guided Erector spinae plane block with Retrolaminar block in pain relief after surgery for kidney stones removal 
Scientific Title of Study   Comparision of post-operative analgesic efficacy of Erector spinae plane block with Retrolaminar block in patients undergoing Percutaneous Nephrolithotomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shah Hemali Bhavin 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhaman Mhavir Medical College and Safdarjung Hospital, Ansari Nagar West

South
DELHI
110029
India 
Phone  8779641841  
Fax    
Email  hemali020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arushi Gupta 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhaman Mhavir Medical College and Safdarjung Hospital, Ansari Nagar West

South
DELHI
110029
India 
Phone  8800550246  
Fax    
Email  drarushigupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arushi Gupta 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhaman Mhavir Medical College and Safdarjung Hospital, Ansari Nagar West

South
DELHI
110029
India 
Phone  8800550246  
Fax    
Email  drarushigupta@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, India, 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Ansari Nagar West, New Delhi 110029 
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 
Shah Hemali Bhavin  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anaesthesia and Intensive Care, 2nd floor Urology OT, SSB Block, Safdarjung Hospital, Ansari Nagar West
South
DELHI 		 8799641841

hemali020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultra-sound guided Erector Spinae Plane Block  Ultra-sound guided Erector Spinae Plane in prone position using 20mL of 0.25% Bupivacaine will be adminstered before commencement of surgical procedure following which analgesic efficicacy will be observed at 1,4,8 and 24 hours postoperatively  
Intervention  Ultra-sound guided Retrolaminar Block   Ultra-sound guided Retrolaminar Block in prone position using 20mL of 0.25% Bupivacaine will be adminstered before commencement of surgical procedure following which analgesic efficicacy will be observed at 1,4,8 and 24 hours postoperatively  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of either gender with American Society of Anaesthesiologists (ASA) physical status Grade I and II, aged 18-65years, undergoing PCNL surgery 
 
ExclusionCriteria 
Details  1. Patients with contraindication to blocks (coagulopathies/ on anticoagulants/ local site infection) 2. Patients with history of allergy to local anaesthetic agents. 3.Patients who have cognitive disability / are unable to understand the VAS score.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post-operative analgesic efficacy of erector spinae plane block with Retrolaminar block in patients undergoing Percutaneous Nephrolithotomy under general anaesthesia using Visual Analogue Scale score   At 1,4,8 and 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the intraoperative Fentanyl requirement    
To compare the time to the first rescue analgesia
 		  
To compare the amount of additional analgesia required post operatively
 		 Over 24 hours 
To compare the patient satisfaction scores post-operatively using Likert scale
 		  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/10/2025 
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 study will compare the postoperative analgesic efficacy of ultrasound-guided erector spinae plane block and retrolaminar block in 80 ASA I–II patients aged 18–65 years undergoing percutaneous nephrolithotomy (PCNL), a procedure associated with significant postoperative pain. While opioids and epidural analgesia are effective, their adverse effects limit routine use, and newer interfascial plane blocks such as erector spinae plane block and retrolaminar block offer safer alternatives, though direct comparative evidence is scarce. Patients will be randomized to receive either erector spinae plane block or retrolaminar block with 20 mL of 0.25% bupivacaine under ultrasound guidance. The primary outcome will be analgesic efficacy, assessed by Visual Analogue Scale (VAS) scores at rest and deep breathing at 1, 4, 8, and 24 hours postoperatively. Secondary outcomes include intraoperative fentanyl consumption, time to first rescue analgesia, total tramadol requirement in 24 hours, postoperative nausea and vomiting, block-related complications, and patient satisfaction using the Likert scale. The study aims to establish whether retrolaminar block provides analgesia comparable to erector spinae plane block with a favorable safety profile, thereby guiding optimal pain management strategies in PCNL. 
Close