| CTRI Number |
CTRI/2021/04/032683 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To Determine Minimum Effective Volume Of Local Anaesthetic In 50% (MEAV50%)Patients Using Dixons Up And Down Method For Ultrasound Guided SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK:ONE YEAR HOSPITAL BASED CLINICAL STUDY |
|
Scientific Title of Study
|
TO DETERMINE MINIMUM EFFECTIVE VOLUME OF LOCAL ANAESTHETIC IN 50% PATIENTS (MEAV50) USING DIXONS UP AND DOWN METHOD FOR ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK:ONE YEAR HOSPITAL BASED CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Killedar |
| Designation |
post graduate |
| Affiliation |
KLE university jawaharlal nehru medical college |
| Address |
2649 Manajrekar Colony Hindalga Belgaum 591108
Belgaum
KARNATAKA
590010
India |
| Phone |
9164361853 |
| Fax |
|
| Email |
NEHAKILLEDAAR@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJESH MANE |
| Designation |
Professor and HOD of Department of Anaesthesia |
| Affiliation |
KLE university jawaharlal nehru medical college |
| Address |
Department of Anesthesiology
KLEs Dr Prabhakar Kore Hospital Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJESH MANE |
| Designation |
Professor and HOD of Department of Anaesthesia |
| Affiliation |
KLE university jawaharlal nehru medical college |
| Address |
Department of Anesthesiology
KLEs Dr Prabhakar Kore Hospital Belgaum
Bagalkot
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Jawaharlal Nehru Medical College. Nehru Nagar Belgaum. 590010 |
|
|
Primary Sponsor
|
| Name |
Department of ananesthesiology |
| Address |
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar Belgaum Karnataka 590010 |
| 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 |
| Dr Neha Killedar |
Department of Anaesthesia |
Department of Anaesthesiology
Kles Prabhakar Kore Hospital Nehru Nagar Belgaum 590010
Belgaum
KARNATAKA |
9164361853
NEHAKILLEDAAR@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee on Human Subjects and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S521||Fracture of upper end of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Ultasound Guided Supraclavicular Brachial Plexus Block. |
A predetermined volume of local anesthetic is injected under ultrasound guidance in a supraclavicular approach of brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
BMI Less Than 35
Elective Upper Limb Surgery |
|
| ExclusionCriteria |
| Details |
ASA 3 & 4
BMI More Than 35
Emergency Surgeries
Upper Limb Deformities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find Minimum Effective Volume of Local Anesthetic in Ultrasound Guided supraclavicular brachial plexus block |
After 30 Mins Of Injecting Drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Toprevent Local Anaesthetic Toxicity. |
After 30 Mins Of Injecting Drug |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will help to find the minimum effective volume of local anaesthetic required for an ultrasound guided supraclavicular brachial plexus block. It helps to prevent the toxicity caused by local anesthetic since lesser volume of drugs are used in subsequent successful cases . This study uses the Dixons up and down method for deciding the volume of the drug. Hence depending on the result of the previous case the subsequent case receives a predetermined volume of drug i,e. 2ml decrease in the volume if the previous case is successful or 2ml increase if the block fails. |