FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090495 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two Ways To Control Pain After Kidney Stone Surgery: A Special Back Injection Versus IV Pain Killers 
Scientific Title of Study   A Randomised Prospective comparative study to assess the post operative analgesic effect of Erector Spinae Plane Block with bupivacaine adjuvant Dexamethasone Versus I.V. Tramadol after Percutaneous Nephrolithotomy Under spinal anesthesia 
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 Varsha Kothari 
Designation  Senior Professor 
Affiliation  SMS MEDICAL COLLEGE 
Address  Department of Anaesthesiology, Second Floor, Dhanwantari Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004 India Jaipur RAJASTHAN 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9828020186  
Fax    
Email  vkothari66@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varsha Kothari 
Designation  Senior Professor 
Affiliation  SMS MEDICAL COLLEGE 
Address  Department of Anaesthesiology, Second Floor, Dhanwantari Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004 India Jaipur RAJASTHAN 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9828020186  
Fax    
Email  vkothari66@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shubham sharma 
Designation  Junior resident 
Affiliation  Sms medical college 
Address  Department of Anesthesiology, Second floor, Dhanwantari Building,SMS Medical College Jaipur,Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  8058710803  
Fax    
Email  Shubhs006@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, SMS Medical College and attached Hospitals, Jaipur, Rajasthan 302004 India 
 
Primary Sponsor  
Name  SMS Medical College and attached hospitals 
Address  JLN Marg, Adarsh Nagar,302004, Jaipur, Rajasthan, 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 shubham sharma  SMS Medical College and attached hospitals  Urology Operation Theatre seventh Floor Super Specialty Building SMS Medical College and Attached Hospitals Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
8058710803

Shubhs006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College and attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N209||Urinary calculus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj tramadol intravenously  Patient will receive inj tramadol 1.5mg/kg intravenously immediately after PCNL surgey 
Intervention  Bupivacaine adjuvant dexamethasone  USG guided erector Spinae Plane Block using 20 ml of 0.25% Bupivacaine adjuvant dexamethasone 8 mg in patient undergoing Percutaneous Nephrolithotomy under Spinal anaesthesia and determine its efficacy for post op analgesia during first 24 hours after procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient scheduled for elective percutaneous nephrolithotomy under spinal anaesthesia
2.ASA GRADING 1-2
3. Patients willing to give informed written consent 
 
ExclusionCriteria 
Details  1. Patient should not be part of other study
2. Non co-operative patient
3. Localised infection at the proposed site of injection
4. Psychiatric illness
5. Coagulation abnormalities
6. Known allergy to local anaesthetics  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mean VAS score
2. Mean time of first rescue analgesia
3. Mean total opioid consumption 
At 2 hour
At 4 hour
At 6 hour
At 8 hour
At 10 hour
At 12 hour
At 16 hour
At 18 hour
At 20 hour
At 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean hemodynamic variables
2. Percentage of block related complication 
Hemodynamic variables, block related complications after block
At 2 hour
At 4 hour
At 6 hour
At 8 hour
At 10 hour
At 12 hour
At 16 hour
At 18 hour
At 20 hour
At 24 hour 
 
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 2 
Date of First Enrollment (India)   15/07/2025 
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="0"
Months="1"
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  

Traditionally, systemic opioids like intravenous tramadol have been employed for postoperative pain management in PCNL due to their centrally acting analgesic properties. However, opioid-based analgesia is not without drawbacks—it often brings along a host of undesirable side effects such as nausea, vomiting, sedation, respiratory depression, and delayed mobilization, which can hinder early recovery. In recent years, the quest for safer and more effective analgesic alternatives has led to increased interest in regional anesthesia techniques, especially interfascial plane blocks. Among these, the Erector Spinae Plane Block (ESPB), first described in 2016, has gained attention for its simplicity, safety profile, and ability to provide both somatic and visceral analgesia.  By depositing local anesthetic in the fascial plane deep to the erector spinae muscle at the level of the transverse process, ESPB facilitates diffusion of the drug to the dorsal and ventral rami of spinal nerves, thereby covering multiple dermatomes. Its application in PCNL has been explored due to the anatomical proximity of the surgical site to the thoracolumbar segments innervating the kidney.


 
Close