| CTRI Number |
CTRI/2019/11/022035 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
UPPER LIMB NERVE BLOCK COMPARATIVE STUDY |
|
Scientific Title of Study
|
COMPARISON BETWEEN INFRACLAVICULAR BRACHIAL PLEXUS POSTERIOR CORD AND LATERAL CORD BLOCK FOR UPPERLIMB SURGERIES UNDER ULTRASOUND GUIDANCE AND NEUROSTIMULATION-A RANDOMIZED DOUBLE BLINDED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M RAMESHRAM |
| Designation |
POST GRADUATE |
| Affiliation |
Kanyakumari government medical college asaripallam |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9047607826 |
| Fax |
|
| Email |
rameshrammurugeswaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR EDWARD JOHNSON |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Kanyakumari government medical college asaripallam |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443392974 |
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M RAMESHRAM |
| Designation |
POST GRADUATE |
| Affiliation |
Kanyakumari government medical college asaripallam |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9047607826 |
| Fax |
|
| Email |
rameshrammurugeswaran@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 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 |
| RAMESHRAM |
Kanyakumari Government Medical College and Hospital |
DEPARTMENT OF ANAESTHESIOLOGY KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM NAGERCOIL TAMILNADU
Kanniyakumari
TAMIL NADU |
9047607826
rameshrammurugeswaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
| Comparator Agent |
NEUROSTIMULATION OF POSTERIOR CORD UNDER ULTRASOUND GUIDANCE |
0.5% BUPIVACINE 20ML using peripheral nerve stimulator for nerve block |
| Intervention |
NEUROSTIMULATION OF LATERAL CORD OF BRACHIAL PLEXUS UNDER ULTRASOUND GUIDANCE |
0.5% BUPIVACINE 20ML using peripheral nerve stimulator for nerve block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 AND 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA PS3 AND 4
BMI MORE THAN 30
PATIENT ON ANTICOAGULANTS
LOCAL INFECTION ,NEUROLOGICAL DISEASES,COAGULOPATHY
ALLERGIC TO LOCAL ANAESTHETICS
PATIENT WITH RESPIRATORY DISEASES |
|
|
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 |
| EXTENT AND EFFECTIVENESS OF SENSORY AND MOTOR BLOCK |
DURATION OF SENSORY AND MOTOR BLOCK ASSESSED |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIME OF FIRST RESCUE ANALGESIA |
COMPARED WITH VAS SCORE |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/11/2019 |
| 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="0"
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:TO determine the extent and effectiveness of block by comparing posterior cord stimulation with lateral cord stimulation by using ultrasound guidance and neurostimulation for infraclavicular brachial plexus blocks for upper limb surgeries. STUDY DESIGN: A p rospective randomised double blinded study SAMPLE SIZE:88 EXPECTED OUTCOME:Stimulating the posterior cord by ultrasound guidance and neurostimulation is associated with greater extent and effectiveness of block than compared with stimulation of lateral cord |