| CTRI Number |
CTRI/2025/04/085778 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Drug concentration comparison in peripheral nerve block for foot surgeries |
|
Scientific Title of Study
|
Comparison of Ropivacaine 0.5 percent and Ropivacaine 0.75 percent in proximal popliteal sciatic nerve block for foot surgeries |
| 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 SHIVANI ARUNKUMAR SOMANI |
| Designation |
Junior Reident |
| Affiliation |
D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA, D Y PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE, KOLHAPUR
DEPARTMENT OF ANAESTHESIA, D Y PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE, KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9890492493 |
| Fax |
|
| Email |
shivani.somani100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RASHMEE VIJAY CHAVAN |
| Designation |
PROFESSOR |
| Affiliation |
D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA, D Y PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE, KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeechavan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVANI ARUNKUMAR SOMANI |
| Designation |
Junior Resident |
| Affiliation |
D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA, D Y PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH CENTRE, KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9890492493 |
| Fax |
|
| Email |
shivani.somani100@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE , KOLHAPUR,MAHARASHTRA ,INDIA-
PIN -416003 |
|
|
Primary Sponsor
|
| Name |
D Y PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH INSTITUTE KOLHAPUR |
| Address |
D Y PATIL MEDICAL COLLEGE , HOSPITAL AND RESEARCH INSTITUTE,KOLHAPUR,MAHARASHTRA,INDIA . PIN-416003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHIVANI ARUNKUMAR SOMANI |
D Y PATIL HOSPITAL, KOLHAPUR, MAHARASHTRA,INDIA |
1st FLOOR , DEPARTMENT OF ANAESTHESIA, D Y PATIL HOSPITAL,KOLHAPUR,MAHARASHTRA
Kolhapur
MAHARASHTRA |
9890492493
shivani.somani100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,D.Y.PATIL MEDICAL COLLEGE, KOLHAPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S908||Other superficial injuries of foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROPIVACAINE 0.50 PERCENT |
IN PATIENTS UNDERGOING FOOT SURGERIES USING REGIONAL POPLITEAL SCIATIC NERVE BLOCK,ONE GROUP WILL RECEIVE ROPIVACAINE 0.50 PERCENT AND WILL BE STUDIED FOR ANALGESIA REQUIREMENT POST OPERATIVELY FOR 24 HOURS. |
| Intervention |
ROPIVACAINE 0.75 PERCENT |
THE OTHER GROUP IN THIS STUDY WILL RECEIVE ROPIVACAINE 0.75% FOR POPLITEAL SCIATIC BLOCK AND WILL BE MONITERED FOR 24 HOURS FOR ANALGESIA POST OPERATIVELY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA grade I , II , III and IV
2)Posted for elective foot surgeries
|
|
| ExclusionCriteria |
| Details |
1)Patient not giving consent for the procedure
2)local skin infections
3)suspected coagulopathy or bleeding diathesis
4)allergy to local anesthetics and study drug
5)patient who cannot be given lateral position
6)BMI>30 kg/m2
-patients requiring midthigh tourniquet for the surgery
7)uncontrolled diabetes mellitus
8)patient with neurodeficit in lower limb
9)patient in whom there is no action or partial action of block even after20 minutes of giving the block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study time of onset of action and duration of analgesia with ropivacaine 0.5% v/s ropivacaine 0.75% |
20 minutes , 4 hours, 8 hours,12 hours,16 hours,20 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study total post operative analgesia requirement |
zero minute,4hr,8,12,16,20,24 hr |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/05/2025 |
| 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="0"
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
|
This study compares the efficacy of ropivacaine in two different concentrations for popliteal sciatic nerve block in foot surgeries. It also focuses on post operative analgesia requirement.
Methodology : Patients are randomised into two groups (Group A and Group B) of 25 patients each using computer generated random method . Group A patients will receive Ropivacaine 0.5%(20cc) and Ropivacaine 0.75%(20cc) through USG guided Popliteal sciatic nerve block.
Following parameters will be recorded - 1)time of onset of action of block 2)Duration of action of block post operatively 3)total analgesia requirement postoperatively for 24 hours |