| CTRI Number |
CTRI/2024/09/074492 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| 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
|
Outcome of Diaphragmatic function after interscalene brachial plexus block |
|
Scientific Title of Study
|
Evaluation of diaphragmatic function after interscalene brachial plexus block with low dose bupivacaine and saline hydrodissection of phrenic nerve |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jalumuru kasi Nikhil |
| Designation |
Junior resident |
| Affiliation |
Sri Devaraj urs academy of higher education and research |
| Address |
Department of Anaesthesiology
Sri devaraj urs academy of higher education and research
Kolar
Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
8073855126 |
| Fax |
|
| Email |
Nikhiljalumuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnuvardhan .V |
| Designation |
Associate professor |
| Affiliation |
Sri Devaraj urs academy of higher education and research |
| Address |
Department of Anaesthesiology
Sri devaraj urs academy of education and research
Kolar
Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9008909768 |
| Fax |
|
| Email |
Ravibabujalumuru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jalumuru kasi Nikhil |
| Designation |
Junior resident |
| Affiliation |
Sri Devaraj urs academy of higher education and research |
| Address |
Room no.1
Department of Anaesthesiology
Sri devaraj ursacademy of higher education and research
Kolar
Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
8073855126 |
| Fax |
|
| Email |
Nikhiljalumuru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri devaraj urs academy of higher education and research |
|
|
Primary Sponsor
|
| Name |
Sri devaraj urs Academy of Higher education and Research |
| Address |
Tamaka
Kolar
Karnatka
563103 |
| 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 JALUMURU KASI NIKHIL |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION |
ANAESTHESIA DEPARTMENT, SRI DEVARAJ MEDICAL COLLEGE AND RESEARCH CENTER
Kolar
KARNATAKA |
9591441163
nikhiljalumuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEVARAJ URS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine 0.5% 15ml through brachial plexus nerve block |
Total duration 18 months |
| Comparator Agent |
Bupivacaine 0.5% 15ml with 10ml normal saline through brachial plexus nerve block |
Bupivacaine With Saline
Total duration 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class1-3
Undergoing elective surgeries on humerus,clavicle,shoulder |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anaesthetic
Severe coagulopathy
Local infection
Pregnancy
Moderate to severe pulmonary dysfunction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine incidence of phrenic nerve paresis |
To determine incidence of phrenic nerve paresis for each patient at baseline, 6 hours and 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the block characteristics |
To evaluate the block characteristics at baseline, day 1 & day 2 post operatively |
|
|
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)
|
08/10/2024 |
| 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 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
|
This study is An observational randomised controlled trial clinical study comparing the efficacy of 15ml of 0.5% bupivacaine with10ml saline and 15ml of 0.5% bupivacaine in one center in India.The primary outcome measures will be To reduce incidence of phrenic nerve paresis and secondary outcome will be onset of sensory blockade and duration of analgesia and patient satisfaction score |