| CTRI Number |
CTRI/2024/02/062540 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two approaches of brachial plexus block in wrist and hand surgeries - a randomized controlled study |
|
Scientific Title of Study
|
A comparative study of ultrasound guided costoclavicular approach of brachial plexus block with axillary approach of brachial plexus block in wrist and hand surgeries - A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Utkalika Baral |
| Designation |
Post Graduate |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
A BLOCK First floor
Department of Anaesthesiology
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7008283656 |
| Fax |
|
| Email |
arjunutkalika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V.Ezhilrajan |
| Designation |
Professor and HOD department of anaesthesiology |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
A BLOCK First Floor
Department of anaesthesiology
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
Ezhilrajan96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E.Shanmugavalli |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
A BLOCK First Floor
Department of anaesthesiology
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College And Hospital Kirumampakkam Pondicherry, 607402 |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College And Hospital |
| Address |
Aarupadai Veedu MedicalCollege And Hospital
Kirumampakkam
Pondicherry Cuddalore Highway
607402 |
| 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 Utkalika Baral |
Aarupadai Veedu Medical College And Hospital |
A BLOCK First Floor
Department of anaesthesiology
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
Kirumampakkam
Pondicherry
PONDICHERRY |
7008283656
arjunutkalika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee aarupadai veedu medical college and hospital |
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: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided axillary block |
Patient undergoing arm and hand surgeries are given Ultrasound guided axillary block with 30ml of 0.75% Ropivacaine to assess the duration of block performance and assess the sensory and motor blockade for 30 minutes |
| Intervention |
Ultrasound guided costoclavicular block |
Patient undergoing arm and hand surgeries are given Ultrasound guided costoclavicular block with 30ml of 0.75% Ropivacaine to assess the duration of block performance and assess the sensory and motor blockade for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age 18-60 years posted for elective forearm and wrist surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. History of hypersensitivity to local Anaesthesia.
3. Hemodynamic instability.
4. Local infection.
5. Coagulopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare block performance time and effectiveness of Usg guided costoclavicular block with USG guided axillary block |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of action
Motor Blockade
Sensory blockade
Complications |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/02/2024 |
| 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
|
Brachial plexus block is a great substitute for general anaesthesia for upper limb surgeries. USG guided axillary block result in anaesthesia of the upper limb from the mid arm down including hand. For adequate spread of drug in the plexus two or three needle pass are required. While Costoclavicular approach due to compact arrangement of plexus around the axillary artery aids in single needle pass. Through this study we aim to compare the performance and effectiveness of both these blocks. |