| CTRI Number |
CTRI/2020/12/029636 [Registered on: 08/12/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the usefulness of a pulse oximeter derived value called perfusion index to detect a successful upper limb block |
|
Scientific Title of Study
|
Evaluation of pulse oximeter perfusion index as an indicator of successful supraclavicular brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar M R |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Anesthesiology, JSS Hospital, Ramachandra Agrahara, Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9945155844 |
| Fax |
|
| Email |
dranilkumarmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha G H |
| Designation |
Junior Resident |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Anesthesiology, JSS Hospital, Ramachandra Agrahara, Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9886854342 |
| Fax |
|
| Email |
gh.smitha1992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha G H |
| Designation |
Junior Resident |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Anesthesiology, JSS Hospital, Ramachandra Agrahara, Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9886854342 |
| Fax |
|
| Email |
gh.smitha1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of Higher Education and Research, Mysuru |
|
|
Primary Sponsor
|
| Name |
Dr Anil Kumar M R |
| Address |
Department of Anesthesiology, JSS Hospital, Ramachandra Agrahara, Mysuru, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Smitha G H |
Department of Anesthesiology, JSS Hospital, Ramachandra Agrahara, Mysuru, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar M R |
JSS Hospital |
Department of Anesthesiology, Third floor, Ramachandra Agrahara 570004
Mysore
KARNATAKA |
9945155844
dranilkumarmr@gmail.com |
|
|
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: W228||Striking against or struck by other objects, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA Physical status class I/II aged 18-60 years undergoing elective hand, wrist and forearm procedures under ultrasound guided supraclavicular block |
|
| ExclusionCriteria |
| Details |
1. Contra-indication to supraclavicular brachial plexus block
2. Pre-existing abnormal neurological or vascular function of either arm ex.: stroke, spasticity, peripheral vascular disease, diabetes, arteriovenous fistulae or extensive burn wounds
3. Allergic reaction to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Simple, non invasive, objective tool to detect a successful supraclavicular brachial plexus block |
30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detect successful supraclavicular brachial plexus block in patients under general anesthesia or otherwise not able to communicate |
30 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a cross sectional study with purposive sampling technique to evaluate the success of pulse oximeter perfusion index as an indicator of successful supraclavicular brachial plexus block that will be conducted in JSS Hospital and JSS Academy of Higher Education and Research, Ramachandra Agrahara Mysuru. The primary objective is to assess perfusion index as a reliable and objective predictor of successful ultrasound guided supraclavicular brachial plexus block and the secondary objective is to provide a cut-off value for the perfusion index and perfusion index ratio for a successful ultrasound guided supraclavicular block. |