FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047105 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 05/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of dexmedetomidine and dexamethasone with ropivacaine to reduce pain in upper limb bone surgeries  
Scientific Title of Study   COMPARISION OF DEXMEDETOMIDINE VS DEXAMETHASONE AS AN ADJUVANT FOR 0.5%ROPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN UPPER LIMB ORTHOPAEDICS SURGERIES 
Trial Acronym  PRCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIRANJAN M 
Designation  POST GRADUATE 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR

Tumkur
KARNATAKA
572107
India 
Phone  9500632100  
Fax    
Email  niranjanmadevan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRSUJAY JN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL TUMKUR

Tumkur
KARNATAKA
572107
India 
Phone  8310859945  
Fax    
Email  drsujayjn79@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DRSUJAY JN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL TUMKUR

Tumkur
KARNATAKA
572107
India 
Phone  8310859945  
Fax    
Email  drsujayjn79@yahoo.com  
 
Source of Monetary or Material Support  
SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,AGALAKOTE,TUMKUR,572107 
 
Primary Sponsor  
Name  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR 
Address  DEPARTMENT OF ANAESTHESIA SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL,TUMKUR 
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 NIRANJAN M  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANESTHESIA SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL TUMKUR 572107
Tumkur
KARNATAKA 		 9500632100

niranjanmadevan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional ethics committe  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  GROUP B - DEXAMETHASONE WITH 0.5% ROPIVACAINE  DEXAMETHASONE 8 MILLIGRAM, SINGLE DOSE, LOCAL INFILTRATION AROUND BRACHIAL PLEXUS 
Intervention  GROUP-A DEXMEDITOMIDINE WITH 0.5% ROPIVACAINE  DEXMEDITOMIDINE 1MICROGRAM/kg, SINGLE DOSE, LOCAL INFILTRATION AROUND BRACHIAL PLEXUS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Patients of ASA physical status grade1 and grade2
•Undergoing upper limb surgery under supraclavicular block.

 
 
ExclusionCriteria 
Details  •Infection at injection site.
•Pre-existing peripheral neuropathy.
•History of allergy to any of the study drugs.
•Peripheral vascular disease.
•Suspected coagulopathy.
•Respiratory illness.
•Uncooperative patients.
•Unwillingness to give consent.
•Patient with history of seizures
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
the onset and duration of motor blockade  5 10 15 20 minutes after injection 
 
Secondary Outcome  
Outcome  TimePoints 
the duration of sensory and motor blockade  0 4 8 12 hours respectively after injection 
 
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)   05/12/2022 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [niranjanmadevan@gmail.com].

  6. For how long will this data be available start date provided 07-11-2022 and end date provided 07-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A hospital based comparative study of  dexmedetomidine vs dexamethasone as an adjuvants for 0.5% ropivacaine in ultrasound guided supraclavicular brachial plexus block.

INTRODUCTION:Ultrasound guided Supraclavicular brachial plexus block (SCPB) is  used for upper limb orthopaedics surgeries with ease, reliability, and a few complication rates. Both addition of dexamethasone and dexmedetomidine have been found to prolong the duration of anaesthesia. However, there has been few studies conducted to compare the effects of dexamethasone and dexmedetomidine added as adjuvants to the ropivacaine for supraclavicular brachial plexus block. This study will be conducted with the primary aim of evaluating the effect of dexmedetomidine to that of dexamethasone as a better medication for a prolonged anesthesia and with minimum complications

ASA grade I & II  patients aged 18-60 years posted for   orthopaedic upper limb  surgeries at Sri Siddhartha Medical College and Research Centre, Tumkur will be selected for the study.Period of  24 months with sample size of 60 patients.

All patients as per inclusion and exclusion criteria posted for elective orthopaedics surgical procedures will be taken in the study

 METHODOLOGY:

The data is collected by convenient sampling .The data will be entered in Excel spread sheet. Descriptive statistical analysis will be carried out. Quantitative variables will be presented as mean and standard deviation and qualitative variables will be presented as frequency and percentages. The association between categorical variables will be analyzed by applying Chi-square test. The data will be analyzed by using SPSS software (version 20).

 
Close