| CTRI Number |
CTRI/2025/08/093555 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two approaches of nerve block for pain relief after kidney stone surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided anterior quadratus lumborum block versus subcostal approach to anterior quadratus lumborum block on post operative analgesia in patients undergoing percutaneous nephrolithotomy- Double blinded randomized controlled 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 Anjana |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam |
| Address |
PG Quaters Phase 1 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry Room no.106 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry Pondicherry PONDICHERRY 605107 India |
| Phone |
9746646367 |
| Fax |
|
| Email |
anjana619s@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Dilip Chandar |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam |
| Address |
Department of Anaesthesia sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry ROOM NO.107 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry Pondicherry PONDICHERRY 605107 India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anjana S |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam |
| Address |
PG quaters phase 1 sri manakula vinayagar medical college madagadipet kalitheerthalkuppam pudhucherry Room no.106 Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry Pondicherry PONDICHERRY 605107 India |
| Phone |
9746646367 |
| Fax |
|
| Email |
anjana619s@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL MADAGADIPET KALITHEERTHALKUPPAM PUDUCHERRY INDIA 605107 |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College |
| Address |
Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry 605107 |
| 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 AnjanaS |
Sri Manakula Vinayagar Medical College |
Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Pudhucherry Pondicherry PONDICHERRY |
09746646367
anjana619s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH -ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Approach Of Anterior Quadratum Lumborum Block |
Conventional Anterior Quadratus Lumborum Block Will Be Given To Patients Posted For Percutaneous Nephrolithotomy Post Operatively |
| Comparator Agent |
Subcostal Approach To Anterior Quadratus Lumborum Block |
Subcostal Approach To Anterior Quadratus Lumborum Block Will Be Given To Patients Posted For Percutaneous Nephrolithotomy Post Operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Asa Ps I,Ii,Iii
-Either Gender
-Patient Posted For Elective Percutaneous Nephrolithotomy
|
|
| ExclusionCriteria |
| Details |
-INFECTION AT INJECTION SITE
-HYPERSENSITIVITY TO LOCAL ANAESTHETICS
-SURGERY DONE UNDER GENERAL ANAESTHESIA. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the block duration by determining the time taken for first rescue analgesic between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.
|
2hours,4hours,8hours,12hours, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the pain scores at rest (resting numeric rating scale score) at specific time intervals post-operatively.
2.To compare the pain scores at ambulation (Dynamic numeric rating scale score) at 12hrs and 24hrs.
3.To compare the total opioid consumption between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.
|
2hours,4hours,8hours,12hours,24hours |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
05/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - anjana619s@gmail.com
- For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
All participants will undergo detailed clinical evaluation, including history, examination, routine and relevant investigations, and pre-anaesthetic assessment on the day prior to surgery. Patients will be briefed about the Numeric Rating Scale (0–10) for pain assessment and randomly allocated into two groups using block randomization: Group C (Conventional anterior quadratus lumborum block) and Group S (Subcostal anterior quadratus lumborum block). Written informed consent will be obtained.
Following standard intraoperative monitoring and spinal anaesthesia (17.5 mg of 0.5 percentage hyperbaric Bupivacaine at L3–L4), patients will undergo percutaneous nephrolithotomy in the prone position. At the end of surgery, Group C will receive a conventional anterior quadratus lumborum block and Group S will receive a subcostal approach, both under ultrasound guidance using 20 ml of 0.25 percentage Bupivacaine. The block technique and time will be recorded.
Postoperative pain will be assessed using NRS at rest (2, 4, 8, 12, 24 hours) and during movement (12, 24 hours). Rescue analgesia (IV Tramadol 0.5 mg/kg) will be administered if NRS greater than or equal to 4, with total 24-hour consumption noted. Hemodynamic parameters and side effects such as nausea, vomiting, site pain, hematoma, or local anaesthetic toxicity will be monitored. All outcome assessments will be done by a blinded observer. |