| CTRI Number |
CTRI/2025/02/080564 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Perfusion Index as a tool for predicting successful ultrasound guided brachial plexus block |
|
Scientific Title of Study
|
Assessment of Perfusion index as a tool for predicting successful ultrasound guided supraclavicular brachial plexus block: an observational cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Manohar Shetty |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Nehru Medical College,Belgaum, Karnataka-590010 |
| Address |
Dept of Anaesthesiology, OT 6, Dr Prabhakar Kore hospital, KLE campus, Nehru nagar, Belgaum, Karnataka, India-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08050488018 |
| Fax |
|
| Email |
manraksh181@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Belgaum, Karnataka-590010 |
| Address |
Dept of Anesthesiology, KLE, KAHER, Belgaum, Karnataka, India-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08050488018 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Belgaum, Karnataka-590010 |
| Address |
Dept of Anesthesiology, KLE, KAHER, Belgaum, Karnataka, India-590010
KARNATAKA
590010
India |
| Phone |
08050488018 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Prabhakar Kore charitable hospital, Belgaum, Karnataka, India-590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical college Belgaum Karnataka India |
| Address |
NRI PG boys hostel, KLE campus, Nehru nagar, Belgaum, Karnataka, India-590010 |
| 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 Manish Manohar Shetty |
Dr Prabhakar Kore Hospital KLE Belgaum Karnataka India 590010 |
Dept of Anesthesiology, OT no 6,Dr Prabhakar Kore Hospital, KLE,Belgaum, Karnataka, India-590010
Belgaum
KARNATAKA |
8050488018
manraksh181@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists(ASA) Physical Status (PS) I and II
2.Patients undergoing elective upper limb surgery under supraclavicular brachial plexus block for this study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate whether the perfusion index (PI) can be used to predict the success of ultrasound guided supraclavicular brachial plexus block.
|
0 min
1 min
2 min
3 min
4 min
5 min
10 min
15 min
20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective: to provide a cut-off value for ultrasound-guided supraclavicular nerve block success.
|
0 min
1 min
5 min
10 min
15 min
20 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/02/2025 |
| 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="0"
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
|
Perfusion
index is a novel tool to be used to assess the success and the efficacy of
ultrasound guided supraclavicular brachial plexus block |