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CTRI Number  CTRI/2020/09/027763 [Registered on: 11/09/2020] Trial Registered Prospectively
Last Modified On: 16/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial of 0.5% Levobupivacaine with Inj .dexamethasone under USG guided supraclavicular brachial plexus block 
Scientific Title of Study   A Clinical Comparison of 0.5% levobupivacaine and 0.5% levobupivacaine with Inj. dexamethasone in elective upper limb surgeries under ultrasound guided supraclavicular brachial plexus block, A randomized double blind interventional study at SMS Medical College - during 2019-2021.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajni mathur 
Designation  Senior professor  
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anaesthesiology 2nd floor Dhanwantri building SMS Medical College jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  rajnimathur@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajni mathur 
Designation  Senior professor  
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anaesthesiology 2nd floor Dhanwantri building SMS Medical College

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  rajnimathur@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chetali das 
Designation  Postgraduate student 
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anaesthesiology 2nd floor Dhanwantri building SMS Medical College

Jaipur
RAJASTHAN
302004
India 
Phone  7891145841  
Fax    
Email  chetalidas@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , SMS Medical College ,JLN Marg ,JAIPUR , RAJASTHAN 
 
Primary Sponsor  
Name  Department of Anaesthesiology SMS Medical College  
Address  JLN Marg ,Jaipur Rajasthan (302004) 
Type of Sponsor  Research institution and hospital 
 
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 Rajni Mathur  SMS Medical College  Department of Anaesthesiology ,JLN Marg
Jaipur
RAJASTHAN 		 9829357194

rajnimathur@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% LEVOBUPIVACAINE WITH 2ml DEXAMETHASONE (8mg)  30 patients will receive 20ml 0.5% levobupivacaine with 2ml dexamethasone (8mg). 
Comparator Agent  0.5% Levobupivacaine with 2ml normal saline  30 patients will receive 20ml 0.5% levobupivacaine with 2ml normal saline in brachial plexus via supraclavicular approach.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  a. Patients undergoing elective upper limb surgeries of duration 1-4 hours
b. Patients belonging to American Society of Anaesthesiologist Grade class-I and  
 
ExclusionCriteria 
Details  a. Patients not willing to participate in the study
b. Uncooperative patients
c. Local infection at the injection site.
d. History of allergy to the study drug.
e. Bleeding disorders, coagulopathies or any other neuropathies 
f. Contra lateral diaphragmatic paralysis
g. Systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To study the difference in the mean time duration for the need of first rescue analgesia .
2.The difference in number of rescue analgesia required within first 24 hrs (postoperative period) in both the groups.
 		 post op numerical rating scale will be used to access the need for rescue analgesia at 30mins,1hr , 1:30mins , 2,4,8,12,34 hrs respectively
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the difference in mean onset and duration of sensory and motor anaesthesia in both the groups.
2. To observe side effects - Nausea, vomiting, convulsions, dryness of mouth, respiratory problems, pneumothorax, etc.
3.Any other side effect and complication
 		 Intra operative - 15,30,45,60,75,105,120minutes
Post operative-0mins,30mins,1, 1:30,2,4,8,12,24hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   19/09/2020 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this trial 60 patients are randomised in 2 groups where one group is given 0.5% LEVOBUPIVACAINE 20ml with 2ml normal saline , the other group is given 0.5% LEVOBUPIVACAINE 20ml with 2ml  inj. dexamethasone..  The need for first resuce analgesia and number of rescue analgesia needed will be assesed. 
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