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CTRI Number  CTRI/2024/04/065028 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare local injection given below collar bone and above collar bone approach using ultrasound for upper limb fractures 
Scientific Title of Study   A prospective comparative study of ultrasound guided paravascular supraclavicular brachial plexus block and costoclavicular approach to infraclavicular brachial plexus block in patients undergoing 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  Dr Nandini CV 
Designation  Associate professor 
Affiliation  Dr B R Ambedkar Medical college and hospital 
Address  Department of Anesthesiology Dr B R Ambedkar medical college and hospital Kg halli Bengaluru -560045

Bangalore
KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandini CV 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar Medical college and Hospital 
Address  Dr B R Ambedkar Medical college and Hospital KG halli Bengaluru-560045

Bangalore
KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nandini CV 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  Dr B R Ambedkar Medical College and Hospital KG Halli Bengaluru-560045

Bangalore
KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr B R Ambedkar Medical College and Hospital kg halli Bengaluru India 560045 
 
Primary Sponsor  
Name  Dr Nandini CV 
Address  Department of Anesthesiology Dr B R Ambedkar Medical College and Hospital Bengaluru 560045 India  
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 Nandini CV  Dr B R Ambedkar Medical college and hsopital  Department of Anaestheiology Dr B R Ambedkar Medical College And Hospital KG Halli Bengaluru 560045 India
Bangalore
KARNATAKA 
9535024072

nandinivraj@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics committee Dr. B.R.Ambedkar Medical college and Hospital  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 
Intervention  costoclavicular approach to infraclavicular block  ultrasound guided infraclavicular block is given with local anesthetic injection bupivacaine 0.5% 25-30ml 
Comparator Agent  Para vascular supraclavicular block  ultrasound guided supraclavicular block is given with local anesthetic injection bupivacaine 0.5% 25-30ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.patients aged 18-65 years
2.patients belonging to American society of anesthesiologist grade 1 and 2
 
 
ExclusionCriteria 
Details  1)known drug allergy to local anaesthetics.
2)patients with any coagulation disorder
3)procedure site infection
4)patients with mental health issues.
5) patients with pulmonary pathology and chest deformity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the time taken for onset of sensory blockade of ultrasound guided Para- vascular supraclavicular approach and costoclavicular approach to infraclavicular brachial plexus block for surgical anaesthesia of upper limb.  From the time of block till the sensory blockade 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the time taken to perform ultrasound guided Para vascular supraclavicular approach & costoclavicular infraclavicular approach to brachial plexus block
2.To study the time taken for onset of motor blockade

3. To know any adverse effects
4.Duration of analgesia
5.Requirement of rescue analgesia for 24 hrs.
 
From the time of block upto 24 hours after the block
 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   05/04/2024 
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 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  

A well conducted regional anesthetic technique has very much to offer to anesthesiologist, surgeon, as well as patients owing to its advantages over general anesthesia such as remaining conscious, avoiding polypharmacy, better hemodynamic stability and excellent post operative analgesia. The introduction of ultrasonography has revived the interest in peripheral nerve blocks. The inherent benefits of direct visualization of nerves and surrounding anatomy, continual observation of needle tip and spread of local anesthetic make ultrasound guided regional anesthesia highly appealing.

 

Infraclavicular brachial plexus block and supraclavicular brachial plexus block provides anaesthesia for arm, forearm and elbow.   Although both supraclavicular and infraclavicular blocks can be utilized for upper limb surgeries, anesthesiologists often have a tendency for supraclavicular over infraclavicular block because of the technical difficulty and increased complications with the blind approach in the latter. The advent of ultrasonography in anesthesia practice has made it a valuable adjunct in peripheral nerve blocks.

 

 Many studies have compared supraclavicular and infraclavicular brachial plexus block but study comparing the ultrasound guided paravascular approach of supraclavicular and costo clavicular approach to infraclavicular brachial plexus block are relatively few. Most of the studies have utilized the corner pocket approach for supraclavicular and lateral parasagittal approach for infraclavicular brachial plexus block. In paravascular approach to brachial plexus block local anesthestic is injected at a single site and hence doesnot require needle repositing.

Similarly costo clavicular approach to infraclavicular brachial plexus block requires single site injection of local anaesthetic until complete blockade is achieved.

The aim is to study para-vascular supraclavicular approach and costo-clavicular approach to infraclavicular brachial plexus block using ultrasound.

 

 
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