| CTRI Number |
CTRI/2021/02/031153 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the use of perfusion index in predicting successful supraclavicular brachial plexus block in upper limb surgeries |
|
Scientific Title of Study
|
Evaluation of perfusion index in predicting successful supraclavicular brachial plexus block for upper limb surgeries: An observational study at S.M.S. Medical College and Attached Group of Hospitals, Jaipur during 2020-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Chandra Sunar |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anesthesiology Dhanvantri building, 1st floor,
SMS Medical College
J.L.N Marg
Adarsh Nagar
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414455100 |
| Fax |
|
| Email |
ramesh.rinku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Sunar |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anesthesiology Dhanvantri building, 1st floor,
SMS Medical College
J.L.N Marg
Adarsh Nagar
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414455100 |
| Fax |
|
| Email |
ramesh.rinku@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kumar Yadav |
| Designation |
PG student |
| Affiliation |
SMS Medical College |
| Address |
Department of Anesthesiology Dhanvantri building, 1st floor,
SMS Medical College
J.L.N Marg
Adarsh Nagar
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9783756727 |
| Fax |
|
| Email |
dr.ramesh.kumar.yadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, SMS Medical College, Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Attached Hospitals |
| Address |
J.L.N Marg
Adarsh Nagar
Jaipur |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kumar Yadav |
SMS Medical College and Attached Hospitals |
Department of Anesthesiology
Dhanvantri building, 1st floor,
Adarsh nagar
Jaipur
Jaipur
RAJASTHAN |
9783756727
dr.ramesh.kumar.yadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I, II.
Patients undergoing elective unilateral upper limb surgery under brachial plexus block. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
History of Diabetes mellitus.
History of peripheral vascular disease. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1. To calculate the mean percentage rise in perfusion index from the baseline in successful blocks.
2. To determine the cut off values for Perfusion Index (PI) and PI ratio that predicts block success. |
30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare PI between blocked and nonblocked limbs.
2. To assess and compare hemodynamic parameters: Heart Rate, SPO2, Systolic Blood Pressure, Diastolic Blood Pressure in successful vs unsuccessful group. |
30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/02/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to investigate whether perfusion index (PI), a measure of peripheral perfusion from a pulse oximetry finger sensor, is a reliable and objective method for assessing the adequacy of supraclavicular blockade and to describe the time course of PI changes once peripheral nerve block has been achieved during surgery. |