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CTRI Number  CTRI/2023/09/057953 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   For forearm and hand surgeries an ultrasound guided comparision between costoclavicular brachial plexus block with supraclavicular brachial plexus block. 
Scientific Title of Study   Comparison of ultrasound guided costoclavicular brachial plexus block versus supraclavicular brachial plexus block for forearm and hand 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  Nandini bynaboina  
Designation  Post graduate resident 
Affiliation  Rangaraya medical college 
Address  Room number 223,GGH pg quarters,Rangaraya medical college,Department of anaesthesia,Kakinada,533001,Andhrapradesh,India.

East Godavari
ANDHRA PRADESH
533001
India 
Phone  6301682351  
Fax    
Email  nandinibynaboina1793@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAVishnu Vardhan 
Designation  Professor  
Affiliation  Rangaraya medical college  
Address  Government general hospital, Kakinada,east Godavari,Andhrapradesh.

East Godavari
ANDHRA PRADESH
533001
India 
Phone  9849577999  
Fax    
Email  athalurivishnu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nandinibynaboina  
Designation  Post graduate resident 
Affiliation  Rangaraya medical college 
Address  Room num 223 ,GGH pg quarters,Rangaraya medical college,department of anaesthesia,Kakinada,533001,andhrapradesh,India.

East Godavari
ANDHRA PRADESH
533001
India 
Phone  6301682351  
Fax    
Email  nandinibynaboina1793@gmail.com  
 
Source of Monetary or Material Support  
Nandini bynaboina , Room num 223, GGH pg quarters,infront of GGH hospital ,ramaraopeta,Kakinada,east odavari,pincode 533001 
 
Primary Sponsor  
Name  Nandinibynaboina  
Address  Room num 223,GGH pg quarters,Kakinada, Andhrapradesh,east godavari. 
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 
DrNandini bynaboina  Government general hospital  Room num 223,ggh pg quarters,ramaraopeta,Kakinada,EastGodavari ,Andhra Pravesh ,533001.
East Godavari
ANDHRA PRADESH 		 6301682351

nandinibynaboina1793@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  Costoclavicular approach for brachial plexus block for upper limb surgeries  Giving nerve block once using 0.5% Bupivacaine 75mg+280mg 2%lignocaine with adrenaline+dexamethasone 4mg,duration :30 minutes 
Comparator Agent  Supraclavicular approach for brachial plexus block for upper limb surgeries  Supraclavicular nerve block once using 0.5% Bupivacaine75mg+280mg 2%lignocaine with adrenaline+dexamethasone 4mg duration; 30 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients posted for forearm and hand surgeries
 
 
ExclusionCriteria 
Details  Patient refusal for consent
Pre-existing neurological deficit or neuropathy affecting brachial plexus.
Bleeding disorders and allergy to local anaesthetics
Pneumothorax
Prior surgery on infra clavicular fossa 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of onset of block and duration of analgesia   During surgery & post operative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Success rate ,performance time,number of needle passes,incidence of adverse effects.  During surgery & post operative day 1 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/09/2023 
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="2" 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Email :nandinibynaboina1793@gmail.com

  6. For how long will this data be available start date provided 10-02-2024 and end date provided 10-02-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The costoclavicular brachial plexus block was recently described as an alternative approach to infraclavicular block.It targets the brachial plexus in the proximal infraclavicular fossa where the lateral ,medial,and posterior cords are tightly bundled together.The compact organization of the plexus at this level,clustered lateral to the artery provides a reliable sensory Motar block when local anaesthetics is deposited between the three cords of the brachial plexus.Costoclavicular space includes a triangular area wedged between the pectoralis major and the subclavius muscle anteriorly and anterior rib cage posteriorly,the goal of costoclavicular approach is to place the needle tip near the clustered cords which is relatively easier than in infraclavicular approach where it is variable and in deeper locations. 
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