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CTRI Number  CTRI/2024/08/072158 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The participants for upper limb surgeries will be given upper limb anaesthesia above the clavicle or below the clavicle to compare the adequacy of upper limb anaesthesia which is the main outcome of this Interventional study  
Scientific Title of Study   A study to compare ultrasound-guided costoclavicular approach with supraclavicular approach for brachial plexus block in upper limb surgeries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta V N  
Designation  MBBS 
Affiliation  M R medial college Kalaburagi  
Address  Department Of Anesthesiology MR Medical College Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9686702444  
Fax    
Email  svnandyal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lata D Shetty 
Designation  MD ANAESTHESIOLOGY  
Affiliation  M R Medical College Kalaburagi  
Address  Department of Anaesthesiology MR Medical college Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9731046446  
Fax    
Email  latads@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Lata D Shetty 
Designation  MD ANAESTHESIOLOGY  
Affiliation  M R Medical College Kalaburagi  
Address  Department Of Anesthesiology MR Medical college Kalaburagi


KARNATAKA
585105
India 
Phone  9731046446  
Fax    
Email  latads@yahoo.co.in  
 
Source of Monetary or Material Support  
Department Of Anesthesiology, Basaveshwara teaching and General hospital attached to Mahadevappa Rampure Medica1 College, Sedam road, Rajapur Kalaburagi-585105 
 
Primary Sponsor  
Name  Basaveshwara teaching and General hospital 
Address  Department Of Anesthesiology Basaveshwara teaching and General hospital attached to Mahadevappa Rampure Medica1 College Sedam road Rajapur Kalaburagi 585105 
Type of Sponsor  Private 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 Lata D Shetty  M R medical College   Department Of Anesthesiology Basaveshwar Teaching and General Hospital Gulbarga 585105
Gulbarga
KARNATAKA 		 9731046446

latads@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical committee M R Medical College Kalaburagi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Y32||Crashing of motor vehicle, undetermined intent,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Costoclavicular approach of brachial plexus block   Brachial plexus block by costoclavicular approach for 18months  
Comparator Agent  Supraclavicular approach of brachial plexus block   Costoclavicular approach of BPB is a modification of ultrasound-guided infraclavicular brachial plexus block. The results showed that the costoclavicular space deserves attention as a potential site for ultrasound guided Infraclavicular brachial brachial plexus block (ICBPB) and encourage future research to compare ICBPB at this site with that at lateral infraclavicular fossa. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Patients posted for upper limb surgeries
-Patients of ASA I,II,III
 
 
ExclusionCriteria 
Details  1- Patients with Neurological disease
2- Local skin infections or disease
3- Patients with bleeding diathesis and coagulopathies
4- History of drug allergy to Local anesthetic (LA)
5- Chronic use of opioids or corticosteroids
6- Psychiatric disorders
7- Pregnant Patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of ultrasound-guided costoclavicular and supraclavicular approach of brachial plexus block   2min,5min,30min,1hr,2hr,4hr 
 
Secondary Outcome  
Outcome  TimePoints 
Time of Onset and duration of sensory and motor blockade in costoclavicular and supraclavicular nerve block   2min,5min,10min,30min,1hr,2hr,4hr 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 4 
Date of First Enrollment (India)   31/08/2024 
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="1"
Months="6"
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 - NO
Brief Summary   The supraclavicular(SC) and infraclavicular(IC) brachial plexus blocks have a similar distribution of anaesthesia, and both can be used effectively for surgeries of upper limb.1 Costoclavicular approach of brachial plexus block (BPB)is a modification of ultrasound-guided infraclavicular brachial plexus block. Under ultrasound guidance, the costoclavicular space (CCS) is visualized as a well-defined intermuscular space, lying deep and posterior to the mid-point of the clavicle. It is located between the clavicular head of the pectoralis major and subclavius muscle anteriorly and the upper slips of the serratus anterior muscle and the second rib posteriorly. All 3 cords of the brachial plexus are visualized in a single transverse sonogram of the CCS as the cords are clustered together lateral to the axillary artery and exhibit a consistent triangular arrangement. The needle can be easily directed to the centre of the plexus with minimal discomfort to patient. 2 Whereas Ultrasound-guided supraclavicular block targets the brachial plexus trunks which gather at the lower part of the interscalene space, surrounding the subclavian artery. This level carries the advantage of being the area where the trunks are most compact. With a high-frequency probe placed parallel and against the clavicle in the coronal oblique plane, the brachial plexus (trunk or division) appears as a cluster of hypoechoic nodules located lateral, posterior, and superior to the subclavian artery (hypoechoic and pulsatile) and just above the underlying first rib (hyperechoic and curvilinear). Care should be taken to avoid intravascular injection of surrounding vessels (i.e., the suprascapular artery or dorsal scapular artery)by using color Doppler. The needle is slowly advanced under direct visualization with an in-plane approach (from lateral to medial) toward the angle formed by the first rib and the subclavian artery.The goal of the supraclavicular technique is to see the spread of local anesthetic reaching the angle between the first rib and the subclavian artery.3 Very few studies are done to compare the efficacy of costoclavicular approach of brachial plexus block with the conventional supraclavicular block. Hence the present study will be undertaken to know the safety and effectiveness of two approaches of Brachial plexus block in upperlimbsurgeries. 
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