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CTRI Number  CTRI/2021/02/031293 [Registered on: 15/02/2021] Trial Registered Prospectively
Last Modified On: 13/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical comparison between a local anaesthetic and local anaesthetic with steroid combination in ultra sonography guided supraclavicular block 
Scientific Title of Study   A clinical comparison between 0.5% levobupivacaine and 0.5% levobupivacaine with dexamethasone 8mg combination under USG guided brachial plexus block by supraclavicular approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha G Hiremath 
Designation  Junior Resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of anaesthesiology Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104 Karnataka India

Bellary
KARNATAKA
534104
India 
Phone  8073830052  
Fax    
Email  anushavidya1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anusha G Hiremath 
Designation  Junior Resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of anaesthesiology Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104 Karnataka India

Bellary
KARNATAKA
534104
India 
Phone  8073830052  
Fax    
Email  anushavidya1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B Devanand 
Designation  Professor and HOD 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of anaesthesiology Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104 Karnataka India

Bellary
KARNATAKA
583104
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Vijayanagar Institute of medical sciences Ballari 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Cantontment, Ballari-583104 
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 
Dr Anusha G Hiremath  Vijayanagar Institute Of Medical Sciences  Department of anaesthesiology, Major OT complex, VIMS Cantontment, Ballari
Bellary
KARNATAKA 
8073830052

anushavidya1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagar Institute Of Medical Sciences Ethics Committee  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  0.5 % LEVOBUPIVACAINE with DEXAMETHASONE 8mg  0.5% LEVOBUPIVACAINE(25ml) + 2ml DEXAMETHASONE (8mg) Dose- 27ml IV administration Frequency- once Duration of therapy- rescue analgesic ( inj.tramadol 100mg IV) will be given once pain score is equal or more than 5 based on NRS  
Comparator Agent  0.5% LEVOBUPIVACAINE  0.5% LEVOBUPIVACAINE (25ml) + 2ml NS(0.9%) Dose- 27ml IV administration Frequency- once Duration of therapy- rescue analgesic ( inj.tramadol 100mg IV) will be given once pain score is equal or more than 5 based on NRS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA class 1 & 2 
 
ExclusionCriteria 
Details  a)Refusal by patients for the block or study.
b)Patients with abnormal BT,CT or on anticoagulation therapy, severe anaemia ,hypovolemia ,shock ,septicaemia and h/o seizures.
c)Local infection at the site of puncture.
d)Allergy to the study drugs.
e)History of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system.
f)Patients who are not co-operative and require additional sedatives.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To know the effect of dexamethasone 8mg with 0.5% levobupivacaine on the duration of post-operative analgesia in ultrasound guided supraclavicular brachial plexus block.  Baseline, 0 min( immediately after drug administration), 1min, 3min,5min, 7min, 10min, 15min,20min, 25min, 30min,45min, 60min,90min, 120min,3hr, 4hr,6hr,12hr,24hr 
 
Secondary Outcome  
Outcome  TimePoints 
a)the onset of sensory and motor blockade.
b)the duration of sensory and motor blockade.
c)hemodynamic variables (HR, BP, O2 saturation).
d)time for first rescue analgesia.
e)total dose of rescue analgesia in 24hrs.
 
Upto 24hrs after giving the block 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   18/02/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Brachial plexus block is a popular and widely employed regional nerve block technique for anaesthesia and postoperative analgesia for surgeries of the upper extremities. Dexamethasone is a very potent and highly selective glucocorticoid used as anti-inflammatory and immunosuppressant. 

Steroids have anti-inflammatory as well as analgesic effects. Many studies have successfully proved the usefulness of dexamethasone as an effective analgesic.

This study is designed to know the beneficial effects of addition of dexamethasone to a local anaesthetic in ultra sound guided brachial plexus block by supraclavicular approach.

 

 
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