| CTRI Number |
CTRI/2024/07/071701 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study that compares the traditional method with the use of a pulse oximeter perfusion index to detect the early effects of a supraclavicular brachial plexus nerve block |
|
Scientific Title of Study
|
Comparison of conventional method versus pulse oximeter perfusion index to determine the early onset of supraclavicular brachial plexus nerve block: An observational 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 |
Ms Deeksha |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, 4th floor, Anaesthesia and Operation Theatre Technology Programme, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8431939513 |
| Fax |
|
| Email |
deekshasuvarna13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvajit Podder |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Hospital |
| Address |
Department of Anaesthesia, Kasturba Medical College Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8050853782 |
| Fax |
|
| Email |
suvajitpodder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Blessing Dhas A |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
3rd floor, Anaesthesia and Operation Theatre Technology Program, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9092743459 |
| Fax |
|
| Email |
blessing.dhas@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital, MAHE, Manipal, Karnataka, India - 576104 |
| Manipal College of Health Professions, MAHE, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Ms. Deeksha |
| Address |
Manipal College of Health Professions, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ms Deeksha |
Kasturba Medical College Hospital, Manipal |
Pre-operative area, Main OT Complex, Operation Theatre, Department of Anaesthesiology, Kasturba
Medical College Hospital, MAHE, Manipal
Udupi
KARNATAKA |
8431939513
deekshasuvarna13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 ( Student Research) |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient aged between 18-60 years undergoing upper arm orthopedic operations under ultrasound guided supraclavicular nerve block.
participants with ASA grading I and II |
|
| ExclusionCriteria |
| Details |
Diabetes mellitus
peripheral vascular disease
mental retardation
pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PI ratio exceeding 1.4 determines the Initiation of supraclavicular brachial plexus block |
2 minutes to 20 minutes post block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in score in Motor blockade, cold sensation & pin prick test indicates onset of block |
2 minutes to 20 minutes post block |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
09/08/2024 |
| 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="0"
Months="8"
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 titled Comparison of conventional method versus pulse oximeter perfusion index to determine the early onset of supraclavicular brachial plexus nerve block: An observational study. Patients of age group 18-60 years old with ASA1 and 2 undergoing upper limb orthopedic procedures will be recruited. The primary objective is to compare pin prick test and pulse oximeter perfusion index to determine the early onset of supraclavicular nerve block. The secondary objective of the study is to compare cold sensation and motor blockade with pulse oximeter perfusion index to determine the early onset of supraclavicular nerve block. |