| CTRI Number |
CTRI/2026/02/104754 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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
|
Comparison of Two Types of Nerve Blocks Used for Forearm Surgery and Their Effect on Breathing |
|
Scientific Title of Study
|
A comparative study of hemidiaphragmatic paralysis
following supraclavicular nerve block versus
costoclavicular nerve block in forearm surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akkamahadevi |
| Designation |
Head of Department , anesthesiology |
| Affiliation |
Doctor moopens medical college |
| Address |
Department of anesthesiology
Moctor moopens medical college
Meppadi
Wayanad
Department of anesthesiology
Doctor moopens medical college
Meppadi
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
8943691336 |
| Fax |
|
| Email |
hod.anesthesiology@drmoopensmc.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akkamahadevi |
| Designation |
Head of Department , anesthesiology |
| Affiliation |
Doctor moopens medical college |
| Address |
Department of anesthesiology
Doctor moopens medical college
Meppadi
wayanad
Department of anesthesiology
Doctor moopens medical college
Meppadi
wayanad
Wayanad
KERALA
673577
India |
| Phone |
7406784848 |
| Fax |
|
| Email |
srujithsruthilayam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akkamahadevi |
| Designation |
Head of Department , anesthesiology |
| Affiliation |
Doctor moopens medical college |
| Address |
Department of anesthesiology
Doctor moopens medical college
Meppadi
Wayanad
Department of anesthesiology
Doctor moopens medical college
Meppadi
wayanad
Wayanad
KERALA
673577
India |
| Phone |
7406784848 |
| Fax |
|
| Email |
srujithsruthilayam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Srujith GS
Department of anesthesiology
Doctor moopens medical college
Meppadi
wayanad
673612
KERALA
INDIA
Srujithsruthilayam@gmail.com |
|
|
Primary Sponsor
|
| Name |
doctor moopens medical college |
| Address |
Department of anesthesiology
Doctor moopens medical college
Meppadi
wayanad
673612
Kerala |
| 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 |
| DR SRUJITH |
doctor moopens medical college |
doctor moopens medical college
meppadi
wayanad
Wayanad
KERALA |
8943691936
MEDICALCOLLEGE@DRMOOPENS.AC.IN |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18 -65 Years of age
ASA- 1 and 2
Upper limb forearm Surgeries
|
|
| ExclusionCriteria |
| Details |
allergic to local anesthetic agent
significant pulmonary disease like Chronic obstructive lung disease ,Interstitial lung disease,Bronchial asthma
BMI more than 35
Cases convert to general anesthesia
Preexisting neuropathy
Coagulopathy
ASA -3 and 4
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hemidiaphragmatic paralysis following supraclavicular versus costoclavicular brachial plexus block |
Assessed 60 minutes after administration of brachial plexus block using ultrasound evaluation of diaphragm movement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in pulmonary function test parameters
diaphragm thickness, & diaphragmatic excursion following supraclavicular versus costoclavicular brachial plexus block
Time Point Baseline before block & 60minutes after administration of the brachial plexus block |
Hemodynamic changes from baseline then upto 60 minutes
Change in pulmonary function test baseline & after 2 hours procedure
Measurement of diaphragm thickness baseline & 2hours after administration of block
Chest xray baseline & 2 hours after administratiion of brachial plexus block |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
TRIAL TITLE : A COMPARATIVE STUDY OF HEMIDIAPHRAGMATIC PARALYSIS FOLLOWING SUPRACLAVICULAR BLOCK VERSUS COSTOCLAVICULAR NERVE BLOCK IN FOREARM SURGERIES STUDY DESIGN : RANDOMISED CONTROL TRIAL SAMPLE SIZE : 20 STUDY SETTING- CONDUCTED AT DEPARTMENT OF ANETHESIOLOGY IN OT SETTINGS AT DOCTOR MOOPENS MEDICAL COLLEGE DURATION : 2 YEARS |