| CTRI Number |
CTRI/2021/01/030527 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Minimum Effective Volume of 0.5 % Ropivacaine(local anaesthetic drug) for Ultrasound guided Costoclavicular block(Infraclavicular Brachial Plexus Block) |
|
Scientific Title of Study
|
Minimum Effective Volume (MEV 90) of 0.5% Ropivacaine for Ultrasound guided Costoclavicular Block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THANUJA B |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
VMMC and Safdarjung Hospital. |
| Address |
Department of Anaesthesiology and Critical Care,VMMC and Safdarjung Hospital,New Delhi.
No.127/2,Ginni house, Gautam nagar(near South cafe restaurant),New delhi,110049.
New Delhi
DELHI
110029
India |
| Phone |
8667821052 |
| Fax |
|
| Email |
thanujabhaskar95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rama Wason |
| Designation |
Professor and Consultant (M.D) |
| Affiliation |
VMMC and Safdarjung Hospital. |
| Address |
Department of Anaesthesiology and Critical Care,VMMC and Safdarjung Hospital,New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9818049948 |
| Fax |
|
| Email |
nupur4@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
THANUJA B |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
VMMC and Safdarjung Hospital. |
| Address |
Department of Anaesthesiology and Critical Care,VMMC and Safdarjung Hospital,New Delhi.
No.127/2,Ginni house, Gautam nagar(near South cafe restaurant),New delhi,110049.
New Delhi
DELHI
110029
India |
| Phone |
8667821052 |
| Fax |
|
| Email |
thanujabhaskar95@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
New Delhi |
| 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 |
| Thanuja |
VMMC and Safdarjung Hospital |
Department of Anaesthesiology and Critical Care, Operation Theatre complex
New Delhi
DELHI |
8667821052
thanujabhaskar95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
To find Minimum effective volume of 0.5% Ropivacaine For Ultrasound guided Costoclavicular Block |
Costoclavicular Block with 0.5% Ropivacaine (initially 20 ml) given and Onset of Sensory and Motor Block assessed by a 3 point scale and Drug Volume is increased or decreased according to block failure or Success respectively and the Minimum Effective Volume is identified |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Adults posted for Elbow Forearm Wrist and Hand surgeries
ASA grade I/II
Body Mass Index 18 to 35 kg /m 2 |
|
| ExclusionCriteria |
| Details |
Sepsis or Infection at the site of Injection
Pre-existing Peripheral Neuropathy and Coagulation disorder
Known Allergy to Local Anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimum Effective Volume of 0.5% Ropivacaine is calculated by titrating the volume of the drug according to block success or failure in previous patient.Block Success is when Minimal Composite score of 14 out of 16 points achieved(Total Composite score is 16;8 for Sensory and 8 for Motor blockade)Onset of Sensory blockade assessed by cold test(0 no block,1 Analgesia-can feel touch not cold,2 Anaesthesia-cannot feel touch)and Motor blockade by a 3 point scale(0 no block,1 paresis,2 paralysis) |
8 time points:time 1, immediately after the procedure;time 2,five minutes after completion of the procedure;time 3,ten minutes after the procedure;time 4, fifteen minutes after the procedure;time 5, twenty minutes after the procedure;time 6, twenty five minutes after the procedure;time 7,thirty minutes after the procedure,time 8,thirty five minutes after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Onset time of blockade(time from the injection of LA to achieving a Minimal Composite score of 14)and block performance time(Sum of Imaging time-Time interval between contact of USG probe and getting a satisfactory picture plus needling time-From Start of Skin wheal to the end of Local Anaesthetic injection) |
8 time points:time 1, immediately after the procedure;time 2,five minutes after completion of the procedure;time 3,ten minutes after the procedure;time 4, fifteen minutes after the procedure;time 5, twenty minutes after the procedure;time 6, twenty five minutes after the procedure;time 7,thirty minutes after the procedure,time 8,thirty five minutes after the procedure |
|
|
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)
|
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="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)?
Response - NO
|
|
Brief Summary
|
The purpose of this prospective interventional study is to evaluate the Minimum effective volume of 0.5 % Ropivacaine for Ultrasound guided Costoclavicular block by starting with a defined volume of drug (20 ml)and titrating according to block success(reducing 2 ml for next patient) and block failure(increasing 2 ml for the next patient) |