| CTRI Number |
CTRI/2021/02/030923 [Registered on: 02/02/2021] Trial Registered Prospectively |
| Last Modified On: |
31/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare Single Point Versus Multipoint Injection in Ultrasound Guided Nerve Block in the arm |
|
Scientific Title of Study
|
Efficacy of Single Point Versus Multipoint Injection in Ultrasound Guided Axillary Plexus Nerve Block - A randomised Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balasubramanian Anusha |
| Designation |
Assistant Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003738506 |
| Fax |
9944579455 |
| Email |
anusha14scorpio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Prasad |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Prasad |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptartment of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
Balasubramanian Anusha |
| Address |
Flat K201 Kensington Block NO 31 Victoria Towers Kazhipattur Kanchipuram 603103 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Balasubramanian Anusha |
Shri Sathya Sai Medical College and Research Institute |
Room number 3 Orthopaedics Department Second Floor OT Complex Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kanchipuram 603108
Kancheepuram
TAMIL NADU |
9003738506
anusha14scorpio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
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: M97-M97||Periprosthetic fracture around internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multipoint Injection Axillary Plexus Nerve Block |
Before the start of surgery random patients coming for upper limb surgeries Multipoint Injection Axillary Plexus Nerve Block will be the anaesthesia technique of choice |
| Intervention |
Single Point Injection Axillary Plexus Nerve Block |
Before the start of surgery random patients coming for upper limb surgeries Single Point Injection Axillary Plexus Nerve Block will be the anaesthesia technique of choice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elbow, forearm & hand surgeries
ASA I-III
|
|
| ExclusionCriteria |
| Details |
Not willing
Patients on anticoagulants
Site of injection being infected
Emergency surgeries of the elbow, forearm & hand
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the time taken for the procedure compared to multiple point injection.
To compare the comfort level of the patient for the procedure
|
Intraoperative Period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess for complication of the single point injection.
To avoid the Musculocutaneous Nerve being spared
|
Intraoperative Period |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
15/02/2021 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised control trial to come the efficacy of single point versus multipoint injection in ultrasound guided axillary plexus nerve block among 188 patients posted for upper limb surgeries over a period of 1 year. The primary objectives are to look for the time taken for the procedure compared to multiple point injection and to compare the comfort level of the patient for the procedure. The secondary objectives are to assess for complication of the single point injection and to avoid the Musculocutaneous Nerve being spared. |