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CTRI Number  CTRI/2022/01/039646 [Registered on: 21/01/2022] Trial Registered Prospectively
Last Modified On: 20/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare anaesthetic effect of two different routes of steroid administration with local anaesthetic for upper limb surgeries. 
Scientific Title of Study   Comparision of Anaesthetic Effect of Perineural versus I.V. Dexamethasone as an Adjuvant to 0.5% Bupivacaine in Ultrasound guided Supraclavicular Brachial Plexus Block in Upper Limb surgeries : a Randomized double Blind Interventional Study at S.M.S.Medical College and Attached Group of Hospitals,Jaipur 2020-2021. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPoonam Kalra 
Designation  Senior Professor 
Affiliation  S.M.S.Medical College 
Address  Department of Anaesthesiology, S.M.S. Medical College, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9413416787  
Fax    
Email  poonamkalra24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPoonam Kalra 
Designation  Senior Professor 
Affiliation  S.M.S.Medical College 
Address  Department of Anaesthesiology, S.M.S. Medical College, Jaipur


RAJASTHAN
302004
India 
Phone  9413416787  
Fax    
Email  poonamkalra24@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNavleen Khurana 
Designation  Post Graduate Resident Doctor 
Affiliation  S.M.S.Medical College 
Address  Department of Anaesthesiology, S.M.S.Medical College, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  8290967387  
Fax    
Email  drnavleenkhurana@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, SMS Medical College, Jaipur 
 
Primary Sponsor  
Name  Department of Anaesthesiology SMS Medical College 
Address  JLN Marg, Jaipur 
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 Navleen Khurana  SMS Medical College, Jaipur  Department of Anaesthesiology, Hand Surgery OT, Dhanwantri OT Complex, Jaipur
Jaipur
RAJASTHAN 		 8290967387

drnavleenkhurana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the ethics committee, SMS Medical College  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 
Comparator Agent  Supraclavicular brachial plexus block with 0.5% bupivacaine and intravenous dexamethasone  36 pateints received 0.5% bupivacaine 20ml for supraclavicular brachial plexus block with 8mg intravenous dexamethasone pre-operatively before surgery and its effect was studied upto 24 hours post-operatively 
Intervention  Supraclavicular brachial plexus with 0.5% bupivacaine and perineural dexamethasone  36 patients received 0.5% Bupivaine 20 ml with perineural dexamethasone 8mg for supraclavicular brachial plexus block pre-operatively before surgery and its effect was studied upto 24 hours post-operatively 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients undergoing elective upper limb surgeries of duration 1-4 hoursd.
2 Patients belonging to American Society of Anesthesiologists Grade class-I and II.
3 Patients with weight between 40 and 80kgs.
4 Patients willing to give written and informed consent

 
 
ExclusionCriteria 
Details  1 Patients not willing to participate in the study
2 Uncooperative patients
3 Local infection at the injection site.
4 History of allergy to the study drug.
5 Bleeding disorders, coagulopathies or any other neuropathies
6 Contra lateral diaphragmatic paralysis
7 Systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery.
8 Patient with history of seizures, peptic ulcer disease, hepatic or renal failure, or septicaemia
9 Patient with a history of traumatic nerve injury, diabetes mellitus, or neuropathy of the surgical limb.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the difference in mean time of onset of sensory and motor block in both groups
 		 At 5, 10, 15 and 20 minutes post procedure
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the difference in duration of analgesia in both groups   Post opertaively upto 24 hours after giving block 
To determine the difference in mean duration of motor block in both groups  Post operatively upto 24 hours after giving block 
To determine the difference in hemodynamic parameters: (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Blood Pressure, Spo2)   Intraoperatively upto 90 minutes and post operatively upto 24 hours 
To determine the difference in percentage of cases who develop adverse effects, if any in both the groups   Upto 90 minutes intaoperatively 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   27/01/2022 
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="3"
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   By comparing two different routes of administration of dexamethasone, perineural and intravenous with 0.5% bupivavaine for supraclavicular brachial plexus block in patients undergoing upper limb surgeries, we can compare which route provides better surgical conditions and better post operative outcome and better post operative analgesia.  
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