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CTRI Number  CTRI/2024/04/066158 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A simple index for assessing success of upper limb block 
Scientific Title of Study   Perfusion index versus conventional method for determining success of Ultrasound guided 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  Ramadevi P 
Designation  Associate Professor  
Affiliation  Velammal Medical College and Research institute  
Address  Department of Anaesthesiology Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady

Madurai
TAMIL NADU
625009
India 
Phone  8695752109  
Fax    
Email  ramatatun16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramadevi P 
Designation  Associate Professor  
Affiliation  Velammal Medical College and Research institute  
Address  Department of Anaesthesiology Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady

Madurai
TAMIL NADU
625009
India 
Phone  8695752109  
Fax    
Email  ramatatun16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramadevi P 
Designation  Associate Professor  
Affiliation  Velammal Medical College and Research institute  
Address  Department of Anaesthesiology Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady

Madurai
TAMIL NADU
625009
India 
Phone  8695752109  
Fax    
Email  ramatatun16@gmail.com  
 
Source of Monetary or Material Support  
Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady Madurai 625009 
 
Primary Sponsor  
Name  Velammal Medical College and Research Institute  
Address  Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady Madurai 625009 
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 Ramadevi   Velammal Medical College and Research Institute   Department of Anaesthesiology Velammal Medical College and Research institute Madurai to Tuticorin ring road Chinthamani Tolgate Anuppanady 625009
Madurai
TAMIL NADU 
8695752109

ramatarun16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Velammal Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 and 60 yr

Undergoing elective upper limb orthopaedic procedures under ultrasound-guided supraclavicular nerve block.  
 
ExclusionCriteria 
Details  Coagulopathy
Allergy to local anaesthetics
Infection at site
Pheriperal vascular disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The prediction of success or failure of supraclavicular block is early when compared to conventional method.
To calculate the perfusion index ratio. 
Baseline,at 10 minutes,15,20,30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To predict the cut-off value for the perfusion index  10 minutes 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   08/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Introduction

 Supraclavicular nerve block is a popular approach for anaesthesia for upper limb surgeries. Conventional methods for evaluation of block success are time consuming and need patient cooperation.

 

Aim

The aim of this study is to evaluate whether the perfusion index (PI) can be used to predict and provide a cut-off value for ultrasound-guided supraclavicular nerve block success.

 

Primary objective

 To compare the conventional method with perfusion index

Secondary objective

      To predict the cut off value for perfusion index

Inclusion  criteria 

Patients aged between 18 and 60 yr who were to undergo elective upper limb orthopaedic procedures under ultrasound-guided supraclavicular nerve block. 

Exclusion criteria were Allergy to drug,Infection,Coagulopathy

 

Methodology

Prospective observational study Sample  size 100 patients 

The supraclavicular nerve block has to be done under usg guidance of a linear transducer over the supraclavicular fossa in the coronal oblique plane immediately superior to the midclavicular point.Patient in semi-sitting position, with the head of the patient turned away from the side to be blocked. 

 

A 22-gauge insulated block needle is in-plane (lateral to medial) to the ultrasound probe. The brachialplexus  will be identified as a compact group of nerves, hypo-echoic, round or oval, located lateral and superficial to the pulsatile subclavian artery and superior to the first rib. A volume of 20ml of localanaesthetic(bupivacaine 0.5%, 10ml and lidocaine 2%, 10 ml) is  injected under vision strictly perineural to surround all the nerve cords.

 

The limb is evaluated for block success every 3 min for the sensory block and every 5 min for the motor block. Sensory function is assessed using pinprick in the dermatomal areas supplied by the four main nerves (median nerve, radial nerveulnar nerve, and musculocutaneous nerve). Motor block assessed by the ability to flex the elbow and the hand against gravity. 

 

The supraclavicular nerve block is considered successful with regard to neurologicalexaminationwhen brachial plexus dermatomes (C5–T1) were completely blocked.

 

The PI  is measured using pulse oximetry applied on the index finger. The PI will be recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters. The PI ratio is  calculated as the ratio between the PI at 10 min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb is  performed.

 

Expected outcome 

        PI when compared to compared to conventional may provide better block success 

 
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