| CTRI Number |
CTRI/2023/07/055520 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of two different volumes of injection Ropivacaine in brachial plexus block in upper limb surgeries |
|
Scientific Title of Study
|
A Comparative Study between two different volumes of 0.5% Ropivacaine in ultrasound guided supraclavicular brachial plexus block for upper limb surgeries. A randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PMU/PMCH/IEC/PG/2022/153 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dishesh Sharda |
| Designation |
PG Resident (Dept. of Anaesthesia) |
| Affiliation |
Pacific Medical College And Hospital |
| Address |
Pacific Medical College And Hospital, Dept. of Anaesthesiology, Bhilon ka Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7889154271 |
| Fax |
|
| Email |
disheshsharda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
Professor And Head Of Dept. (Anaesthesia) |
| Affiliation |
Pacific Medical College And Hospital |
| Address |
Pacific Medical College And Hospital, Dept. of Anaesthesiology, Bhilon ka Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dishesh Sharda |
| Designation |
PG Resident (Dept. of Anaesthesia) |
| Affiliation |
Pacific Medical College And Hospital |
| Address |
Pacific Medical College And Hospital, Dept. of Anaesthesiology, Bhilon ka Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7889154271 |
| Fax |
|
| Email |
disheshsharda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College And Hospital, Department of Anaesthesia, Bhilon Ka Bedla, Udaipur, Rajasthan, 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College And Hospital |
| Address |
Department of Anaesthesia, Pacific Medical College And Hospital, Bhilon Ka Bedla, Udaipur, Rajasthan |
| 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 Prakash Chandra Audichya |
Pacific Medical College And Hospital |
Department of Anaesthesia, Pacific Medical College And Hospital, Bhilon Ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN |
9929721889
prakash.audichya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College And Hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S520||Fracture of upper end of ulna, (2) ICD-10 Condition: S521||Fracture of upper end of radius, (3) ICD-10 Condition: S522||Fracture of shaft of ulna, (4) ICD-10 Condition: S523||Fracture of shaft of radius, (5) ICD-10 Condition: S525||Fracture of lower end of radius, (6) ICD-10 Condition: S526||Fracture of lower end of ulna, (7) ICD-10 Condition: S62||Fracture at wrist and hand level, (8) ICD-10 Condition: S568||Injury of other muscles, fascia and tendons at forearm level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Ropivacaine 0.5% 20ml |
Injection Ropivacaine 0.5% 20ml given as local anaesthetic agent in forearm surgeries |
| Comparator Agent |
Injection Ropivacaine 0.5% 30ml |
Injection Ropivacaine 0.5% 30ml given as local anaesthetic in forearm surgeries |
| Intervention |
Injection Ropivacaine 0.5% given as local anaesthetic in supra clavicular brachial plexus block |
To compare Injection Ropivacaine 0.5% 30ml with Injection Ropivacaine 0.5% 20ml as local anaesthetic in supra clavicular brachial plexus block in fore arm surgeries for a duration of 24 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-60 years
American Society of Anesthesiologists Physical Status I and II
Scheduled for elective upper limb surgeries under Supraclavicular block
Body weight between 50-80 kgs.
|
|
| ExclusionCriteria |
| Details |
Lack of patient consent
ASA grade III, IV, V
Patients with anticipated difficult intubation- Mallampati Grade 3 and 4
Any other Co-morbidities (COPD, Ischemic Heart Disease, Hypertension, Diabetes Mellitus, Renal & hepatic Dysfunction, etc.)
Allergic to local anesthetics
Coagulation disorder
Pregnancy
Body weight less than 50 kgs and more than 80 kgs
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of onset of Motor block & Sensory block
Duration of Motor block & Sensory block
Time taken for first analgesic dose |
24months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any side effects
Haemodynamic stability |
24months |
|
|
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)
|
22/07/2023 |
| 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="2"
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
|
Study to compare time of onset, efficacy and duration of motor and sensory block with two different volumes (30ml and 20ml) of Injection Ropivacaine 0.5% when given as ultrasound guided supra clavicular brachial plexus block in upper limb surgeries so that we can use low volume of local anaesthetic agent to achieve desired effect of anaesthesia. |