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CTRI Number  CTRI/2021/09/036351 [Registered on: 08/09/2021] Trial Registered Prospectively
Last Modified On: 07/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO COMPARE THE EFFECTS OF ULTRASOUND-GUIDED BLOCK AT SHOULDER LEVEL WITH AND WITHOUT DEXAMETHASONE TO 0.5% LEVOBUPIVACAINE. 
Scientific Title of Study   TO COMPARE THE EFFECTS OF ULTRASOUND-GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK WITH AND WITHOUT DEXAMETHASONE AS AN ADJUVANT TO 0.5% LEVOBUPIVACAINE. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anshil Bhatia 
Designation  Pg 1st year Anaesthesia  
Affiliation  School of medical sciences & Research 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9896618924  
Fax    
Email  anshil.bhatia@sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti Srivastava  
Designation  Professor & Head of Department 
Affiliation  School of medical sciences & Researc 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9811966766  
Fax    
Email  aarti.srivastava@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aarti Srivastava  
Designation  Professor & Head of Department 
Affiliation  School of medical sciences & Researc 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida

Balrampur
UTTAR PRADESH
201310
India 
Phone  9811966766  
Fax    
Email  aarti.srivastava@sharda.ac.in  
 
Source of Monetary or Material Support  
Sharda Hospital 
 
Primary Sponsor  
Name  Sharda Hospital 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida 
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 Anshil Bhatia  Shara Hospital  Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
09896618924

anshil.bhatia@sharda.ac.in 
 
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: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LEVOBUPIVACAINE  Ultrasound- guided Supraclavicular Brachial plexus block (1)Onset of sensory and motor blockade (2)To record the total duration of sensory and motor blockade.(3)To observe the number of rescue analgesia given for post-operative pain relief. 
Intervention  LEVOBUPIVACAINE WITH AN ADJUVANT DEXAMETHASONE  Ultrasound- guided Supraclavicular Brachial plexus block (1)Onset of sensory and motor blockade (2)To record the total duration of sensory and motor blockade.(3)To observe the number of rescue analgesia given for post-operative pain relief.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1& 2.
Patients scheduled for ortho upper limb surgeries.
 
 
ExclusionCriteria 
Details  1. Coagulopathy or anti-coagulation treatment.
2. History of allergy to local anesthetic.
3. Infection at the site of injection.
4. Significant neurological and psychiatric.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To record onset and total duration of sensory and motor blockade.


 

To record onset(for 20 mins) and total duration (for 24 hrs)of sensory and motor blockade. 
 
Secondary Outcome  
Outcome  TimePoints 
To record the total duration of sensory and motor blockade and to observe the number of rescue analgesia given for post-operative pain relief.  24 hrs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/09/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The brachial plexus block is commonly performed procedure in anaesthetic practice today. It is used for analgesia as well as anaesthesia in upper limb procedures. This achieves near ideal operative conditions by producing complete muscular relaxation maintaining stable intraoperative haemodynamics and reduces post-operative pain, vasospasm and edema. Bupivacaine 0.5% is one of the most commonly used local anaesthetic agents because of its higher potency and prolonged duration of action. One of the drawbacks of bupivacaine is its cardiotoxicity which is near fatal, especially when injected accidentally into the artery. Levobupivacaine(S-enantiomer of Bupivacaine) local anaesthetic agent as it has a longer duration of action. However it has limiting factors like delayed onset, patchy and incomplete analgesia. Dexamethasone has been studied as an adjuvant to local anaesthetic in peripheral nerve block. Steroids have nerve block prolonging effects by blocking transmission of nociceptive myelinated c-fibres and suppressing ectopic neuronal discharge. They are also thought to alter the function of potassium channels in the excitable cells. Thus, dexamethasone is selected as an adjuvant to local anaesthetic (levobupivacaine) in a study because it has been reported to prolong duration of action of local anaesthetics with no respiratory depression. This in turn will help in titrating the dose of Bupivacaine there by optimizing this technique of analgesia.

Dexamethasone is added to levobupivacaine to improve quality and duration of action thus providing for postoperative analgesia. Some studies suggest that when used as an adjuvant to peripheral nerve block in upper limb surgery, dexamethasone may prolong duration of sensory block and are effective in reducing postoperative pain intensity and opioid consumption.

 
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