CTRI Number |
CTRI/2020/03/023898 [Registered on: 12/03/2020] Trial Registered Prospectively |
Last Modified On: |
31/08/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
A prospective observational study to evaluate the use of pulse oximeter perfusion index as a predictor of successful supraclavicular brachial plexus nerve block. |
Scientific Title of Study
|
A prospective observational study to evaluate the use of pulse oximeter perfusion index as a predictor of successful supraclavicular brachial plexus nerve 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 Manish Patil |
Designation |
Assistant Professor |
Affiliation |
B.Y.L.Nair Ch. Hospital and T.N. Medical college, Mumbai central |
Address |
Department of Anaesthesiology,
B.Y.L.Nair Ch. Hospital and T.N. Medical college, Mumbai central
Mumbai MAHARASHTRA 400008 India |
Phone |
9004025170 |
Fax |
|
Email |
drmanishpatil@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Snehal Chavan |
Designation |
Senior Resident |
Affiliation |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central |
Address |
Department of Anaesthesiology,
B.Y.L.Nair Ch. Hospital and T.N. Medical college, Mumbai central
Mumbai MAHARASHTRA 400008 India |
Phone |
7841871740 |
Fax |
|
Email |
chavan2318@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Snehal Chavan |
Designation |
Senior Resident |
Affiliation |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central |
Address |
Department of Anaesthesiology,
B.Y.L.Nair Ch. Hospital and T.N. Medical college, Mumbai central
MAHARASHTRA 400008 India |
Phone |
7841871740 |
Fax |
|
Email |
chavan2318@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology,BYL Nair Ch Hospital And TN Medical college Mumbai central |
|
Primary Sponsor
|
Name |
BYL Nair Ch Hospital And TN Medical college Mumbai central |
Address |
B.Y.L.Nair Ch. Hospital and T.N. Medical college, Mumbai central 400008 |
Type of Sponsor |
Government 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 Snehal Chavan |
Department of Anaesthesiology,BYL Nair Ch. Hospital mumbai |
BYL Nair Ch. Hospital And TN medical COLLEGE, MUMBAI CENTRAL EAST Mumbai MAHARASHTRA |
7841871740
chavan2318@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee for academic research projects (ECARP) T.N. Medical college & B.Y.L. Nair Ch. Hospital, Mumbai |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S424||Fracture of lower end of humerus, (2) ICD-10 Condition: S423||Fracture of shaft of humerus, (3) ICD-10 Condition: S422||Fracture of upper end of humerus, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
American Society of Anaesthesiology Grade I and II |
|
ExclusionCriteria |
Details |
1) Patients with diabetes mellitus
2) Patients with peripheral vascular disease |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess success of supraclavicular block using perfusion index |
baseline, 10 mins, 20 mins, 30 mins |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
20/03/2020 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Supraclavicular brachial plexus block provides dense anaesthesia to the upper arm, elbow and forearm. The superficial placement of the plexus at this site leads to good sonographic visualisation and a quick procedure that is well tolerated by patients in operating room. The improved safety afforded by the use of ultrasound allowing the visualisation of pleura has likely being the turning point in the increased use of supraclavicular blockade as a mode of anaesthesia for upper limb surgeries and hence it is routinely performed. There are numerous methods for assessment of brachial block success. One of the methods for assessment of peripheral nerve blocks is by assessing the sensory and motor function using pin prick for sensory blockade and motor function assessment for motor blockade which are subjective, time consuming and needs a lot of patients cooperation. Others are objective methods like changes in skin temperature, vasodilation and changes in blood flow. The perfusion index is the ratio of the pulsatile blood flow to the non pulsatile or static blood in peripheral tissue. Perfusion index thus represents a non invasive measure of peripheral perfusion that can be continuously and non invasively obtained from pulse oximeter |