| CTRI Number |
CTRI/2024/09/073810 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| 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 outcomes of pain relief between local anaesthetic infiltration and erector spinae plane block after percutaneous nephrolithotomy surgery. |
|
Scientific Title of Study
|
Evaluation of efficacy of local anaesthetic infiltration of the incision site and erector spinae plane block for postoperative analgesia in patients undergoing percutaneous nephrolithotomy .- A randomised open label study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B VAISHNAVI |
| Designation |
Junior resident, Department of Anaesthesia |
| Affiliation |
Shri B M Patil medical college and hospital |
| Address |
Department of Anaesthesia, Shri B M Patil medical college and hospital, Vijayapura, Karnataka.
Bijapur
KARNATAKA
586103
India |
| Phone |
8639771938 |
| Fax |
|
| Email |
vaishnavibombay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B VAISHNAVI |
| Designation |
Junior resident, Department of Anaesthesia |
| Affiliation |
Shri B M Patil medical college and hospital |
| Address |
Department of Anaesthesia, Shri B M Patil medical college and hospital, Vijayapura, Karnataka.
KARNATAKA
586103
India |
| Phone |
8639771938 |
| Fax |
|
| Email |
vaishnavibombay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B VAISHNAVI |
| Designation |
Junior resident, Department of Anaesthesia |
| Affiliation |
Shri B M Patil medical college and hospital |
| Address |
Department of Anaesthesia, Shri B M Patil medical college and hospital, Vijayapura, Karnataka.
KARNATAKA
586103
India |
| Phone |
8639771938 |
| Fax |
|
| Email |
vaishnavibombay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil medical college and hospital |
| Address |
Department of Anaesthesia, Shri B M Patil medical college and hospital, Vijayapura, Karnataka.586103. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrVijay V Katti |
Shri BM Patil medical college and hospital |
Department of anaesthesiology,BLDE Deemed to be university,Solapur road,Vijayapura,Karnataka,India,Bijapur karnataka
Bijapur
KARNATAKA |
9844585900
drvijaykatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE(Deemed to be university) Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local anaesthetic of the incision site |
20 ml of 0.25% bupivacaine with 8 mg of dexamethasone is given in the form of local infiltration |
| Intervention |
Ultrasound guided Erector spinal plane block |
20ml of 0.25%bupivacaine with 8 mg of dexamthasone is given in the form of erector spine plane block at the level of T10 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing percutaneous nephrolithotomy .
Age 18–60 years
American Society of Anesthesiology (ASA) physical status I and II
|
|
| ExclusionCriteria |
| Details |
Bleeding diathesis
Patients in renal failure .
A dermal infection in the injection site . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare postoperative pain relief using the Numerical rating scale (NRS)between the two groups. |
30min, 60min, 2nd hour,4th hour,6th hour,12th hour,18th hour, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare time of first analgesic requirement in both groups and tramadol consumption in both groups. |
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
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2024 |
| 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="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 study is about comparing the postoperative pain relief in patients who receive local anaesthetic infiltration of the incision site and erector spinal plane block who undergo percutaneous nephrolithotomy . |