| CTRI Number |
CTRI/2024/04/065437 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To determine the efficacy between two nerve blocks in upper extremity surgeries |
|
Scientific Title of Study
|
Efficacy of Intertruncal Vs classical approach of Supraclavicular brachial plexus block for upper extremity surgery : a double blinded randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revathi Manogaran |
| Designation |
Post graduate |
| Affiliation |
Post graduate |
| Address |
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9600754320 |
| Fax |
|
| Email |
revathimano97@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjan R V |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjan R V |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Revathi Manogaran |
| Address |
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry |
| 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 |
| DrRevathi Manogaran |
Sri manakula vinayagar medical college and hospital |
Room number 109
First floor
Department of anesthesiology
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
Pondicherry
PONDICHERRY |
9600754320
revathimano97@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
classical approach of supraclavicular brachial plexus nerve block |
onset of sensory and motor block and efficacy between two blocks |
| Comparator Agent |
intertruncal approach of supraclavicular brachial plexus nerve block |
onset of sensory and motor block and efficacy between two blocks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I to III
Adult Age group- 18 to 75 years old
Operative site at the elbow, forearm, wrist or hand |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Intertruncal Vs Classical Approach of Supraclavicular Brachial Plexus Block for upper extremity surgery in a sample size of 60 |
To determine the onset of sensory and motor block in 5,10,15,20 ,25 and 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare total duration of sensory and motor blockade between the two groups. |
total duration measured in minutes for every 5mins after the block |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Supraclavicular block once described as the “spinal anaesthesia of the arm†because of greater safety due to real time ultrasound guidance and better block dynamics.1 The supraclavicular approach to the brachial plexus characteristically associated with the rapid onset of anaesthesia and has high success rate.1-2 Supraclavicular block offers dense anaesthesia of the brachial plexus for surgical procedures at or distal to the elbow.3-8 There are various ways of providing brachial plexus block through supraclavicular approach which includes multiple injection spanning from 6’o clock position, 12’o clock position of supraclavicular artery. This approach is called as classical approach, this provides excellent block characteristics. However, intraneural injections can be devastating complication in this approach which can result in permanent injury to brachial plexus. To prevent this complication double injection technique - known as intertruncal approach (IA) which aims to provide satisfying block dynamics of the entire brachial plexus while avoiding intraneural injection, in which local anaesthetic (LA) is accurately deposited to adipose tissue planes between the upper and middle , middle and lower trunks. However it’s a new procedure with varying results reported in few of the studies conducted. The purpose of this study is to compare the onset time efficacy in Intertruncal Vs Classical approach of supraclavicular brachial plexus block. |