| 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
|
|
|
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
|
|
|
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 nerve, ulnar 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 |