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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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  
Outcome  TimePoints 
nil 
 
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
 
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