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CTRI Number  CTRI/2025/07/091009 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To determine a better method for assessment of successful supraclavicular brachial plexus block 
Scientific Title of Study   COMPARATIVE EVALUATION OF CHANGE IN PERFUSION INDEX AND SENSORY FUNCTION TESTS IN DETERMINING SUCCESSFUL SUPRACLAVICULAR BRACHIAL PLEXUS 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 Shaleen Bhardwaj 
Designation  Primary DNB 
Affiliation  NDMC Medical College and Hindu Rao Hospital 
Address  Department of Anesthesiology, NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  7906543719  
Fax    
Email  drshaleenbhardwaj.sb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Kumar Gupta 
Designation  HOD & CMO SAG 
Affiliation  NDMC medical college and Hindu rao hospital 
Address  Department of anesthesiology,NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  9810655949  
Fax    
Email  drskgupta4u@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shaleen Bhardwaj 
Designation  primary dnb 
Affiliation  NDMC medical college and Hindu rao hospital 
Address  Ground floor OT, Department of Anesthesiology NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  7906543719  
Fax    
Email  drshaleenbhardwaj.sb@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  NDMC medical college and Hindu rao hospital 
Address  NDMC medical college and Hindu Rao Hospital, malkaganj, delhi-110007 
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 Shaleen Bhardwaj  NDMC Medical college and Hindu Rao Hospital   Ground floor OT, Department of Anaesthesiology,Hindu rao hospital, Malka ganj, delhi
Central
DELHI 		 07906543719

drshaleenbhardwaj.sb@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
 
 
ExclusionCriteria 
Details  patient refusal
known drug allergy
coagulation disorder
local site infection, peripheral neuropathy
patients using analgesic medications including opiodS and NSAIDS 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
to observe and compare the changes in perfusion index and tactile response to pin prick sensation following supraclavicular block  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
observe & compare the changes in perfusion index, perfusion index ratio & tactile response to cold touch after the block  8 weeks 
to observe any side effects or complications  8 weeks 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/08/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drshaleenbhardwaj.sb@gmail.com].

  6. For how long will this data be available start date provided 15-07-2025 and end date provided 31-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   As we delve into this comparative evaluation we aim to assess if there are any discernible differences in the reliability of the perfusion index and sensory function tests to predict successful supraclavicular block, if these methods correlate in identifying failed blocks or complications and if the perfusion index can serve as a valuable adjunct to, or even a replacement for traditional sensory assessments in clinical practice. 
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