| 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
|
|
|
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
|
|
|
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.
|