| CTRI Number |
CTRI/2024/10/075672 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study between 0.5 percent Ropivacaine and 0.5 percent Ropivacaine with Verapamil as an adjuvant in USG guided supraclavicular brachial plexus block in upper limb surgeries. |
|
Scientific Title of Study
|
A Randomised Comparative Study between 0.5 percent Ropivacaine and 0.5 percent Ropivacaine with Verapamil as an adjuvant in Ultrasound guided supraclavicular brachial plexus block in upper limb 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. Vijay Chahar |
| Designation |
Associate Professor |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anaesthesia,Pacific Medical College and Hospital,Bhilon ka bedla,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
08015805823 |
| Fax |
|
| Email |
chaharvijay03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Angu Mukunthan |
| Designation |
PG Resident |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of Anaesthesia, Pacific Medical College and Hospital, Bhilon ka Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
08015805823 |
| Fax |
|
| Email |
angumukunthan1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Angu Mukunthan |
| Designation |
PG Resident |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anaesthesia,Pacific Medical College and Hospital,Bhilon ka bedla,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
08015805823 |
| Fax |
|
| Email |
angumukunthan1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College and Hospital,Bhilon ka bedla,N.H.27,Pratap Pura,Girwa,Udaipur,Rajasthan
313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Department Of Anaesthesia, Pacific Medical College and Hospital,Bhilon ka bedla,N.H.27,Pratap Pura,Girwa,Udaipur,Rajasthan
313001 |
| 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 S Angu Mukunthan |
Pacific Medical College and Hospital |
Department Of Anaesthesia, Pacific Medical College and Hospital, Bhilon ka Bedla, Udaipur
Udaipur
RAJASTHAN |
08015805823
angumukunthan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S500||Contusion of elbow, (2) ICD-10 Condition: S602||Contusion of wrist and hand, (3) ICD-10 Condition: S614||Open wound of hand, (4) ICD-10 Condition: S503||Other superficial injuries of elbow, (5) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5 percent Ropivacaine with Verapamil |
Inj Ropivacaine 0.5 percent(30ml) with Verapamil 2.5mg (1ml) in USG guided supraclavicular brachial plexus block in upper limb surgeries from the injection of drug till 24 hours
|
| Intervention |
0.5 Percent Ropivacaine |
Inj Ropivacaine 0.5 percent (30ml) with normal saline (1ml) in USG guided supraclavicular brachial plexus block in upper limb surgeries from the injection of drug till 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged between 18-60 years.
2. American society of Anesthesiologists (ASA) Physical Status I and II.
3. Patient weighing between 50kgs-80kg
4. Patients scheduled for elective upper limb surgeries under Supraclavicular block.
|
|
| ExclusionCriteria |
|
|
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 |
1. To study the onset and duration of sensory blockade
2. To study the onset and duration of motor blockade
|
1.From the time of injecting the drug till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken for rescue analgesic and dose
2.Haemodynamic parameters
3.Complications if any
|
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 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
|
To know the onset and duration of sensory and motor blockade using injection ropivacaine alone and injection ropivacaine with verapamil in supraclavicular brachial plexus block for upper limb surgeries. |