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CTRI Number  CTRI/2021/08/035448 [Registered on: 05/08/2021] Trial Registered Prospectively
Last Modified On: 04/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of addition of drugs Dexmedetomidine and Dexamethasone to regional nerve block of upper extremity surgeries 
Scientific Title of Study   COMPARISON BETWEEN DEXMEDETOMIDINE AND DEXAMETHASONE AS ADJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED 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  Dr Laveena Basil Consera 
Designation  Junior Resident 
Affiliation  Jubilee Mission Medical College and Research Institute 
Address  Jubilee Mission Medical College and Research Institute Department of Anesthesiology Eastfort Thrissur

Thrissur
KERALA
680005
India 
Phone  9074506232  
Fax    
Email  laveenabasil94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sugatha Prakash 
Designation  Professor 
Affiliation  Jubilee Mission Medical College and Research Institute 
Address  Jubilee Mission Medical College and Research Institute Department of Anesthesiology Eastfort Thrissur

Thrissur
KERALA
680005
India 
Phone  9633397003  
Fax    
Email  sugatha234@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sugatha Prakash 
Designation  Professor 
Affiliation  Jubilee Mission Medical College and Research Institute 
Address  Jubilee Mission Medical College and Research Institute Department of Anesthesiology Eastfort Thrissur

Thrissur
KERALA
680005
India 
Phone  9633397003  
Fax    
Email  sugatha234@gmail.com  
 
Source of Monetary or Material Support  
Jubilee Mission Medical College and Research Institute, Thrissur 
 
Primary Sponsor  
Name  Jubilee Mission Medical College and Research Institute 
Address  Jubilee Mission Medical College and Research Institute Eastfort Thrissur Pin code: 680005 
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 Laveena Basil Consera  Jubilee Mission Medical College and Research Institute  Depeartment of Anesthesiology, Old block, Jubilee Mission Medical College and Research Institute, Eastfort, Thrissur Pin code: 680005
Thrissur
KERALA 
9074506232

laveenabasil94@gmail.com 
 
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: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Solution 1  Inj. Ropivacaine 0.75% 10 ml with Inj. Dexmedetomidine 30 mcg, diluted to a total of 30 ml  
Intervention  Solution 2  Inj. Ropivacaine 0.75% 10 ml with Inj. Dexamethasone 3000 mcg (3 mg), diluted to a total of 30 ml 
Comparator Agent  Solution 3  Inj. Ropivacaine 0.75% 10 ml diluted to 30 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age from 18 years to 65 years
2. American Society of Anaesthesiologists (ASA) physical status class I and II
3. Patients scheduled for upper limb surgeries at the level of mid shaft of humerus and below
 
 
ExclusionCriteria 
Details  1. Patient refusal for study participation
2. Local infection at injection site
3. Presence of any coagulopathies, bleeding disorders or patients on anticoagulants
4. Presence of neurological deficits, peripheral neuropathies, myopathies or chronic pain in the operating limb
5. Patients with known allergy to local anaesthetics or to any of the study drugs to be used
6. Patients with baseline bradycardia or on beta blockers/alpha agonists
7. Hemodynamically compromised patients
8. Alcoholic/psychiatric/uncooperative patients
9. Pregnant and breast-feeding mothers
10.Patients with diabetes, hepatic/renal or cardiopulmonary disorders
11.Morbid obesity 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset and duration of sensory and motor blockade  Onset of sensory and motor blockade will be assessed every 3 minutes after the completion of injection upto 60 minutes.

Duration of sensory and motor blockade will be assessed in the first 24 hours after block. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of analgesia
2. Hemodynamic parameters during surgery 
Duration of analgesia is the time from commencement of block to patient’s first request for rescue analgesic in the first 24 hours.

Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation and respiratory rate will be recorded for first 6 hours. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   08/08/2021 
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="0"
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  
Pain can result in physiological changes in the intraoperative period and psychological effects postoperatively. Regional anesthesia has been used as a sole anesthesia technique and as supplementary to general anesthesia. The brachial plexus blockade is a time-tested technique for upper limb surgeries. The search for better adjuvants to local anesthetics for nerve blocks for rapid onset, prolonged duration of analgesia and with lesser side effects has been never ending. Various adjuvants like opioids, neostigmine, midazolam, hyaluronidase, alpha 2 adrenergic receptor agonists, corticosteroids, and epinephrine have been used to modify the onset of action, enhance the quality of block, and prolong the duration of post-operative analgesia. In this study, we aim to evaluate Dexmedetomidine and Dexamethasone as adjuvants to Ropivacaine in comparison to Ropivacaine alone for ultrasound guided brachial plexus block. The minimum sample size comes to 25 in each group. In this study, 30 patients will be taken up in each group for proper randomization and exclusion of any patient due to block failure. The study will be conducted in the Department of Anesthesiology, Old block, Jubilee Mission Medical College and Research Institute, Thrissur.
 
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