| CTRI Number |
CTRI/2025/09/094734 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of hemi-diaphragmatic dysfunction after ultrasound guided costoclavicular and supraclavicular brachial plexus block in upper extremity surgery in healthy adult population. |
|
Scientific Title of Study
|
Comparative evaluation of hemi-diaphragmatic dysfunction after ultrasound-guided costoclavicular and supraclavicular brachial plexus block in upper extremity surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akansha |
| Designation |
PG Resident |
| Affiliation |
ESI-PGIMSR HOSPITAL AND COLLEGE BASAIDARAPURR |
| Address |
Main OT 3rd floor,Department of anaesthesia,ESI-PGIMSR HOSPITAL AND COLLEGE,BASAIDARAPUR,NEW DELHI
West
DELHI
110015
India |
| Phone |
9958992140 |
| Fax |
|
| Email |
hoodaakansha1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Virender kumar mohan |
| Designation |
professor |
| Affiliation |
ESI-PGIMSR HOSPITAL AND COLLEGE BASAIDARAPUR |
| Address |
Main OT 3rd floor,Department of anaesthesia,ESI-PGIMSR HOSPITAL AND COLLEGE,BASAIDARAPUR ,NEW DELHI
West
DELHI
110015
India |
| Phone |
9891557705 |
| Fax |
|
| Email |
dr_vkmohan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Virender kumar mohan |
| Designation |
professor |
| Affiliation |
ESI-PGIMSR HOSPITAL AND COLLEGE BASAIDARAPUR |
| Address |
Main OT 3rd floor,Department of anaesthesia,ESI-PGIMSR HOSPITAL AND COLLEGE, BASAIDARAPUR, NEW DELHI
West
DELHI
110015
India |
| Phone |
9891557705 |
| Fax |
|
| Email |
dr_vkmohan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR HOSPITAL AND COLLEGE,BASAIDARAPUR,NEW DELHI,INDIA
PIN CODE-110015 |
|
|
Primary Sponsor
|
| Name |
Dr Akansha |
| Address |
Main OT 3rd floor,Department of anaesthesia,ESI-PGIMSR HOSPITAL AND COLLEGE
BASAIDARAPUR,NEW DELHI,INDIA
PIN CODE-110015 |
| 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 Akansha |
ESI-PGIMSR HOSPITAL AND COLLEGE,BASAIDARAPUR,NEW DELHI |
MAIN OT 3RD FLOOR, DEPARTMENT OF ANAESTHESIA
West
DELHI |
9958992140
hoodaakansha1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESI-PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
costoclavicular brachial plexus block |
type of brachial plexus block to anaesthetise brachial plexus for upper arm surgeries |
| Intervention |
Nil |
Nil |
| Comparator Agent |
supraclavicular brachial plexus block |
gold standard used for upper arm surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade one and two
scheduled for upper limb surgeries |
|
| ExclusionCriteria |
| Details |
pre existing respiratory diseases
allergy to local anaesthetics
local infection
coagulopathy and anticoagulants use
pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of diaphragmatic paralysis in both blocks |
20 minutes after giving the blocks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| elevation of hemidiaphragm on chest radiograph |
24 hours after block
|
| time of onset of complete neural blockade in both blocks |
at 0,2,4,6,8,10,15,30,60 minutes after giving block |
| time taken from local injection to needle withdrawal after injecting drugs in both blocks |
at the time of giving blocks |
| time for fisrt analgesia |
to be measured after giving the block |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/09/2025 |
| 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="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A recent modification of infraclavicular brachial plexus block is costoclavicular brachial plexus block.It is carried out directly behind the collarbone, where brachial plexus’s three cords form a tight cluster allowing for quick and dependable blockage and uniform sonoanatomy.It is compared with gold standard supraclavicular block which have comparatively higher incidence of hemi diaphragmatic paralysis. The purpose of this study is to determine whether costoclavicular brachial plexus block is less likely to cause hemi diaphragmatic paresis compared to supraclavicular block. Although introduction of ultrasound and regional anaesthesia techniques has significantly enhanced both safety and effectiveness. |