| CTRI Number |
CTRI/2017/09/009763 [Registered on: 14/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Brachial Plexus Block For Upper Limb operation |
|
Scientific Title of Study
|
Randomized Comparison Of Hemidiaphragmatic Function Following Ultrasound Guided Supraclavicular Versus Costoclavicular Brachial Plexus Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAVEEN KUMAR G |
| Designation |
POST GRADUATE |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLAGE AND RESEARCH INSTITUTE |
| Address |
A04 Sreendhi Block, Agrini Apartment, 78 TPK Road , Andalpuram , Madurai
Madurai
TAMIL NADU
625003
India |
| Phone |
9442900166 |
| Fax |
|
| Email |
naveen.aims08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T SIVASHANMUGHAM |
| Designation |
PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLAGE AND RESEARCH INSTITUTE |
| Address |
DOOR NO. 34, ANUGRAHA HOUSES, PONDY - CUDDALORE Main Road, PUDUCHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9442505567 |
| Fax |
|
| Email |
drsiva95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR INDUBALA MAURYA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLAGE AND RESEARCH INSTITUTE |
| Address |
House no:13,3rd Cross Street, Jayanagar , Reddiyarpalayum
Puducherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
7639769237 |
| Fax |
|
| Email |
Indubala.maurya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical Collage, Pondy - Cuddalore Main road , Pillaiyarkuppam , Puducherry |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and research institute |
| Address |
mahatma gandhi medical collage, pondy - cuddalore road , pillaiyarkuppam 607403 |
| 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 |
| naveen kumar |
mahatma gandhi medical collage and research institute |
2nd floor , ot complex, department of anesthesia
Pondicherry
PONDICHERRY |
9442900166
naveen.aims08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S52||Fracture of forearm, patient undergoing right upper limb surgery with ASA grade 1 & 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ultrasound costoclavicular block |
In group CC ,the ipsilateral arm will be abducted to 90 degree and the transducer will be placed just below and parallel to the medial half of the clavicle. Initial aim to identify the subclavian artery (pulsating hypo echoic and non-collapsible structure) and the subclavian vein (collapsible and hypo echoic structure) lying cephalad to the artery. Brachial plexus elements will be visualized lateral to the artery as multiple, round to oval hypoechoic structures surrounded by an outermost hyperechoic fascial layer. The brachial plexus will be approached with the nerve block needle inserted either in-plane or out-of-plane depending on the ergonomics achieved and 20 ml of same LA mixture will be injected below the outermost hyper echoic line (Subfacial). Time of removal of needle will be considered as Time 0. After 30 minutes the US assessment of ipsilateral diaphragmatic movement and Peak expiratory flow will be recorded as described earlier. |
| Intervention |
ultrasound guided supraclavicular |
In Group SC, ipsilateral arm will be positioned by the side of the patient and the transducer will be placed parallel to and above the clavicle. The initial aim is to identify the subclavian artery, as a hypoechoeic and pulsatile structure, on top of the first rib. In the optimized sonogram, the trunks and division of the brachial plexus are visualized as multiple hypoechoic round to oval structures lying superior and lateral to the subclavian artery. The brachial plexus elements are also embedded in a hyperechoeic connective tissue matrix and collectively surrounded by a hyperechoeic fascial layer, the brachial plexus sheath, which is best visualized deep to the clavicle. The brachial plexus will be approached with the nerve block needle inserted either in plane or out-of-plane depending on the ergonomics achieved and the operator’s convenience. 20 ml of equal mixture of 0.5% bupivacaine and 2% xylocaine with adrenaline will be deposited within the brachial plexus sheath (Subfacial). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status 1 & 2
2.Elective / Emergency surgery of the upper extremity
|
|
| ExclusionCriteria |
| Details |
1.Unwilling patients
2.Patients who are unable to understand and perform forced vital capacity maneuvour.
3.Patient with history suggestive of any kind of respiratory disease.
4.Patients who are allergic to the LA test doses
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of complete hemi diaphragmatic paralysis diagnosed by Ultrasonography. |
before block and 30 minute after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional outcome (PEFR) |
before block and 30 minute after block |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2017 |
| Date of Study Completion (India) |
25/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
we designed this study to analyse the hemi diaphragmatic function and compare the incidence of phrenic nerve palsy following two different ultrasound guided techniques of the brachial plexus block namely the supraclavicular versus Costoclavicular approach. HYPOTHESIS : US guided Costoclavicular approach to the brachial plexus block is associated with lower incidence of hemi diaphragmatic paralysis |