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CTRI Number  CTRI/2023/08/056590 [Registered on: 17/08/2023] Trial Registered Prospectively
Last Modified On: 16/08/2023
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 study to Compare perineural intravenous dexamethasone on glycemic profile in non diabetic patients undergoing supraclavicular brachial plexus block.  
Scientific Title of Study   Comparison of perineural & intravenous dexamethasone on glycemic profile in non diabetic patients undergoing supraclavicular brachial plexus block  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishitha Shetty 
Designation  PG Resident 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9663126687  
Fax    
Email  shettynishitha094@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Leena H Parate 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Leena H Parate 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College Bnagalore 
 
Primary Sponsor  
Name  M S Ramaiah Medical College 
Address  Department of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore 560054 
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 
Nishitha Shetty  M S Ramaiah Medical College  Department of Anesthesiology Second floor M S Ramaiah Medical College New Bel Road Bangalore Karnataka
Bangalore
KARNATAKA 		 9663126687

shettynishitha094@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical Collegee Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fractures of upper limbs Glycemic profile  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% Ropivacaine and I.V dexamethasone 4 mg   25 ml of 0.5% Ropivacaine and after completion of block I.V dexamethasone 4 mg will be administered.  
Intervention  0.5% ropivacaine with 4 mg dexamethasone (perineural)   25 ml 0.5% ropivacaine with 4 mg dexamethasone (perineural) will be injected. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All the Non Diabetic Patients undergoing Supraclavicular brachial plexus block who fit into
ASA (American Society Of Anesthesiology) Grade I/II
 
 
ExclusionCriteria 
Details  Subjects with pre-existing diabetes mellitus patients (FBS> 126 mg/dl, Post prandial blood sugars (PPBS>200mg/dl).
Chronic steroids therapy.
History allergy to dexamethasone.
Pregnancy.
Immunosuppressed patients.
Patients Refusal.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The aim of the study is to compare blood glucose concentration in perineural & intravenous dexamethasone group.
 
Finger prick capillary blood sugar values will be measured at baseline before block, after 1 hour,2 hours, 3 hours, 4 hours, 5 hours, 6 hours using glucometer.  
 
Secondary Outcome  
Outcome  TimePoints 
To study the duration of post operative analgesia (Visual analogue score4).
 		 The duration of analgesia, is defined as the interval between the completion of local anesthetic injection & the first administration of analgesics. (Visual analogue score 4) The duration of analgesia will be recorded. 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   30/08/2023 
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="2"
Months="0"
Days="0" 
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 - NO
Brief Summary  

Dexamethasone is a local anesthetic adjuvant and widely used perineurally to enhance the effects of brachial plexus block. Studies have revealed that dexamethasone can prolong the time of local anesthetic nerve block analgesia. Steroids have nerve block prolonging effects by blocking transmission of nociceptive myelinated c-fibers and suppressing ectopic neuronal discharge.

They are also thought to alter the function of potassium channels in the excitable cells. Dexamethasone has been reported as an excellent adjuvant to enhance the post op analgesia in supraclavicular brachial plexus block.

Dexamethasone in various doses (4mg to 8mg) has been used. In perioperative setting, low dose(<10mg) dexamethasone is administered primarily for nausea and vomiting prophylaxis.

Dexamethasone has been reported to increase blood glucose concentration in both diabetic and non-diabetic patients. There are varying results of perioperative of dexamethasone on blood glucose concentration, some studies have reported no increase in blood glucose concentration where as there are few studies that has shown there is increase in blood glucose concentration.

 
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