| CTRI Number |
CTRI/2020/02/023167 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine effective dose of dexmedetomidine when added to ropivacaine to produce efficient ultrasound guided supraclavicular brachial plexus block in surgeries of arm |
|
Scientific Title of Study
|
Comparing different doses of dexmedetomidine combined with ropivacaine for ultrasound guided supraclavicular brachial plexus block in upper limb surgeries - A prospective randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Akshara |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8248392805 |
| Fax |
|
| Email |
drp.akshara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
|
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Akshara |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai medical college and research institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
|
| Fax |
|
| Email |
drp.akshara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 503108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
P Akshara |
| Address |
G-3, Block 2, Nithiyam shruthi apartments, No 2/5, NRN Street, Villivakkam |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| P Akshara |
Shri Sathya Sai Medical College and Research Institute |
Department of anaesthesia II floor OT complex OT no 1 2 3 SURGERY and ORTHO OT Second
Floor OT Complex Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 503108 Tamil Nadu India
Kancheepuram
TAMIL NADU |
8248392805
drp.akshara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M80-M85||Disorders of bone density and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
At the beginning of surgery, Dexmedetomidine 25 mcg as an adjuvant with 29ml of 0.5% Ropivacaine given in supraclavicular brachial plexus block |
| Intervention |
Dexmedetomidine |
At the beginning of surgery, Dexmedetomidine 50 mcg as an adjuvant with 29ml of 0.5% Ropivacaine given in supraclavicular brachial plexus block |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective upper limb surgeries
American Society of Anaesthesiologist I or II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with pre existing peripheral neuropathy of upper limb
Patients allergic to local anesthetics
Patients on adrenoreceptor agonist/ antagonist therapy
American Society of Anaesthesiologist III and above Patients with coagulation disorders
Local site infection
BMI above 30
Poorly controlled Hypertension
Poorly controlled Diabetes mellitus
Severe CVS abnormalities
Renal/Hepatic insufficiency
Pregnancy/ Lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia of two different doses of dexmedetomidine in terms of first rescue analgesia requirement |
Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensorimotor blockade
Peri operative analgesic requirements
Sedation
Hemodynamic stability |
Peri operative Period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
05/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript is under consideration in a journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a randomized controlled trial to compare the efficacy of different doses of Dexmedetomidine when combined with Ropivacaine in supraclavicular brachial plexus block among 50 patients posted for upper limb surgeries over a period of 18 months. The primary objective is to compare the duration of analgesia post-operatively. The secondary outcomes are to assess the onset and duration of sensorimotor block, peri operative analgesic requirement, sedation score and hemodynamic stability. |