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
|
|
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
|
|
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. |