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CTRI Number  CTRI/2024/12/077542 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Perfusion Index for early identification of ulnar nerve sparing in superaclavicular block for hand surgery 
Scientific Title of Study   An observational study to evaluate Perfusion Index (PI) as tool for early detection of ulnar nerve sparing after superaclavicular block. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jigisha Bharatbhai Mehta 
Designation  Associate Professor 
Affiliation  Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, 
Address  New OT Complex, 2nd floor, Dhiraj Hospital, Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
390024
India 
Phone  8866718168  
Fax    
Email  jbmehta28@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jigisha Bharatbhai Mehta 
Designation  Associate Professor 
Affiliation  Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, 
Address  New OT complex, 2nd floor, Dhiraj Hospital, Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
390024
India 
Phone  8866718168  
Fax    
Email  jbmehta28@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jigisha Bharatbhai Mehta 
Designation  Associate Professor 
Affiliation  Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, 
Address  New OT Complex, 2nd floor, Dhiraj Hospital, Smt B.K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
390024
India 
Phone  8866718168  
Fax    
Email  jbmehta28@yahoo.co.in  
 
Source of Monetary or Material Support  
Smt B.K.Shah Medical Institute and Research center, Piparia, Waghodia, Vadodara- 391760. Gujarat, India. 
 
Primary Sponsor  
Name  Smt B.K.Shah Medical Institute and Research center 
Address  Smt B.K.Shah Medical Institute and Research center. Sumandeep Vidyapeeth deemed to be university, Piparia, Waghodiya, Vadodara, Gujarat 
Type of Sponsor  Research institution and hospital 
 
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 Jigisha B Mehta  Dhiraj Hospital, Sumandeep Vidyapeeth deemed to be university.  New OT Complex, 2nd Floor, ,Dhiraj Hospital, Vidyapeeth deemed to be university, Piparia, Waghodiya, Vadodara, Vadodara.
Vadodara
GUJARAT 		 8866718168

jbmehta28@yaahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, (2) ICD-10 Condition: S569||Injury of unspecified muscles, fascia and tendons at forearm level, (3) ICD-10 Condition: S529||Unspecified fracture of forearm,  
 
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  1.Patient undergoing upperlimb surgery under superaclavicular brachial plexus block
2.American Society of Anaesthesiology (ASA) physical status I AND II  
 
ExclusionCriteria 
Details  1.Known contraindications to nerve block like local infection, coagulopathy, allergy to
local anaesthetics
2.Diabetic neuropathy
3.Peripheral vascular disease
4.Neurological deficit in operative upper limb
5.Patients with injury to index/ring finger that preclude application of SpO2 probe  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perfusion Index on ring finger and Index finger  before block, immediately after block, 1,2,3,4,5,6,7,8,9,10,13,16,19,22 min 
 
Secondary Outcome  
Outcome  TimePoints 
Perfusion Index ration on ring finger and Index finger  before block, immediately after block, 1,2,3,4,5,6,7,8,9,10,13,16,19,22 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/12/2024 
Date of Study Completion (India) 21/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jbmehta28@yahoo.co.in].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-11-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This observational study will help us to evaluate Perfusion Index (PI) as tool for early detection of ulnar nerve sparing after superaclavicular block. It will help us to detect ulnar nerve sparing early than conventional methods so we can give isolated ulnar nerve block early and thus prevent wastage of time as well as we can improve patient’s and surgeon’s convenience.   
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