| CTRI Number |
CTRI/2024/12/077554 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound guided comparison of Supraclavicular versus Costoclavicular Brachial plexus block for elective forearm surgeries |
|
Scientific Title of Study
|
Ultrasound guided comparison of Supraclavicular versus Costoclavicular approaches to Brachial plexus block for forearm surgeries:Randomized Controlled 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 |
Anooj Mohan L |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department OF Anaesthesiology
Government Medical College
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8547268886 |
| Fax |
|
| Email |
dranoojmohanl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal T Modi |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department Of Anaesthesiology
Government Medical College
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9712998276 |
| Fax |
|
| Email |
komaltmodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal T Modi |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department Of Anaesthesiology
Government Medical College
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9712998276 |
| Fax |
|
| Email |
komaltmodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Government Medical College Vadodara |
|
|
Primary Sponsor
|
| Name |
Government Medical College Vadodara |
| Address |
Department Of Anaesthesiology
Government Medical College
Vadodara |
| Type of Sponsor |
Government 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 Anooj Mohan L |
Government Medical College Vadodara |
Trauma Operation Theatre
1st Floor,New Surgical Block
Government Medical College
VADODARA
Vadodara
GUJARAT |
8547268886
dranoojmohanl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Biomedical And Health Research,Government Medical College,Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Supraclavicular Approach To Brachial Plexus Block |
Supraclavicular Block
For USG guided SCB, patient will be positioned supine with a small roll beneath shouldered head turned to the contralateral side.The arm to be blocked will be kept adducted and hand will be rested over the abdomen.
The transducer should be positioned transversely immediately proximal to clavicle at its midpoint.The brachial plexus will be seen as a collection of hypo echoic structures superficial to the artery posteriorly.Needle position should be confirmed with saline dissection. Inj Levobupivacaine 10ml should be given to supraletral aspect of artery and another 10ml should be given infra medial aspect of subclavian artery.A total amount of 20ml Inj Levobupivacaine 0.5% is to be given around subclavian artery. |
| Comparator Agent |
USG GUIDED COSTOCLAVICULAR APPROACH TO BRACHIAL PLEXUS BLOCK |
COSTOCLAVICULAR BLOCK
For USG guided CCB, patient should be positioned supine, with ipsilateral arm abducted for the scan and the head was turned slightly to the contralateral side.The transducer will be placed transversely distal to the clavicle directly over the midpoint of clavicle.The 3 cords of the brachial plexus will be clearly visualised lateral to Axillary artery.Needle position will be confirmed by saline dissection. Inj Levobupivacaine 0.5% 10ml to be injected around the medial cord and posterior cord.Subsequently Inj Levobupivacaine 0.5%10ml to be injected to the lateral cord. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 20-60 yr of either gender
Patients with ASA I-II status
Scheduled to undergo unilateral forearm surgeries
Able to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with coagulopathy
Local site infections and anatomical deformity
Hypersensitivity to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to achieve complete block |
Till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory and motor block characteristics between two groups
Success rate of blocks
Haemodynamic parameters
Incidence of adverse events |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
11/12/2024 |
| 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="1"
Months="0"
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
|
Our purpose of the study is to compare block performance time of brachial plexus block via USG guided supraclavicular and USG guided costoclavicular approaches, block success rate, sensory and motor block characteristics and incidence of any adverse events in patients undergoing elective forearm surgeries under ultrasound guidance. |