| CTRI Number |
CTRI/2019/07/020189 [Registered on: 15/07/2019] Trial Registered Prospectively |
| Last Modified On: |
13/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
UPPER LIMB NERVE BLOCK COMPARATIVE STUDY |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CORACOID APPROACH AND RETROCLAVICULAR APPROACH OF INFRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPER LIMB SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S VIGNESH |
| Designation |
POST GRADUATE |
| Affiliation |
KANYAKUMARI GOVT MEDICAL COLLEGE ASARIPALLAM |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KANYAKUMARI GOVT MEDICAL COLLEGE
ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9003574775 |
| Fax |
|
| Email |
dr.vicky1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
EDWARD JOHNSON |
| Designation |
PROFESSOR |
| Affiliation |
kanyakumari govt medical college |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KANYAKUMARI GOVT MEDICAL COLLEGE
ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
|
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
EDWARD JOHNSON |
| Designation |
PROFESSOR |
| Affiliation |
kanyakumari govt medical college |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KANYAKUMARI GOVT MEDICAL COLLEGE
ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
|
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
|
Source of Monetary or Material Support
|
| HOD DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM |
|
|
Primary Sponsor
|
| Name |
kanyakumari government medical college |
| Address |
Department of anaesthesiology
kanyakumari government medical college hospital
asaripallam |
| 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 |
| VIGNESH |
Kanyakumari Government Medical College and Hospital |
Department of Anaesthesiology
ASARIPALLAM
Kanniyakumari
TAMIL NADU |
9003574775
dr.vicky1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CORACOID APPROACH |
NEEDLE INTRODUCED 2CM MEDIAL TO CORACOID PROCESS AND 2CM INFERIOR TO CLAVICLE |
| Comparator Agent |
RETROCLAVICULAR APPROACH |
NEEDLE INSERTED JUST BELOW THE CLAVICLE TO APPROACH POSTERIOR CORD |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS I and II
Elective upper limb surgeries
|
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA PS III and IV
Airway disease
Local infections
Neurological diseases
allergy to local anaesthetics
Coagulopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Needle visibility
Block success rate
Number of needle passes
Block performance time
Procedure related pain
Complications |
sensory and motor blockade will be assessed at the end of 20mins after performance of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient and operator comfort and satisfaction
complications |
Start of block performance till 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/07/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM AND OBJECTIVE TO COMPARE CORACOID APPROACH AND RETROCLAVICULAR APPROACH OF INFRACLAVICULAR BLOCK IN UPPER LIMB SURGERIES PROSPECTIVE RANDOMIZED CONTROLLED TRIALS SAMPLE SIZE:110 EXPECTED OUTCOME:RETROCLAVICULAR APPROACH MAY BE THE GOOD ALTERNATIVE TO CORACOID APPROACH IN INFRACLAVICULAR BRACHIAL PLEXUS BLOCK |