| CTRI Number |
CTRI/2022/09/045450 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs, dexamethasone and dexmedetomidine given as a regional anesthesia in patients undergoing surgeries for forearm and hand. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF DEXAMETHASONE AND DEXMEDETOMIDINE AS ADJUVANTS TO 0.5% ROPIVACAINE IN AXILLARY BLOCK. A PROSPECTIVE RANDOMIZED CONTROLLED DOUBLE BLIND STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANANDA N V |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MANIPAL HOSPITAL WHITEFIELD |
| Address |
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
Bangalore
KARNATAKA
560066
India |
| Phone |
9686585584 |
| Fax |
|
| Email |
shivananda.nadiminti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHIVANANDA N V |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MANIPAL HOSPITAL WHITEFIELD |
| Address |
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
Bangalore
KARNATAKA
560066
India |
| Phone |
9686585584 |
| Fax |
|
| Email |
shivananda.nadiminti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIVANANDA N V |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MANIPAL HOSPITAL WHITEFIELD |
| Address |
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
MANIPAL HOSPITAL WHITEFIELD
ITPL MAIN ROAD
KRISHNARAJAPURA
BANGALORE
Bangalore
KARNATAKA
560066
India |
| Phone |
9686585584 |
| Fax |
|
| Email |
shivananda.nadiminti@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANIPAL HOSPITAL WHITEFIELD |
|
|
Primary Sponsor
|
| Name |
MANIPAL HOSPITAL BANGALORE |
| Address |
MANIPAL HOSPITAL
98, HAL OLD AIRPORT ROAD, KODIHALLI, BANGALORE
560017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| SHIVANANDA N V |
MANIPAL HOSPITAL WHITEFIELD |
ANAESTHESIA
ORTHOPAEDICS
PLASTIC SURGERY
GENERAL SURGERY
ONCOSURGERY
Bangalore
KARNATAKA |
9686585584
shivananda.nadiminti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MANIPALHOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M719||Bursopathy, unspecified, (2) ICD-10 Condition: M200||Deformity of finger(s), (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (4) ICD-10 Condition: M674||Ganglion, (5) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, (6) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ROPIVACAINE WITH DEXAMETHASONE |
30ML OF 0.5% ROPIVACAINE AND 2ML OF DEXAMETHASONE (8MG) ADMINISTERED IN AXILLARY BRACHAIL PLEXUS BLOCK |
| Intervention |
ROPIVACAINE WITH DEXMEDETOMIDINE |
30ML OF 0.5% ROPIVACAINE WITH 2ML OF DEXMEDETOMIDINE (1mcg/kg) ADMINISTERED IN AXILLARY BRACHIAL PLEXUS BLOCK |
| Comparator Agent |
ROPIVACAINE WITH NORMAL SALINE |
30ML OF 0.5% ROPIVACAINE WITH 2ML NORMAL SALINE ADMINISTERED IN AXILLARY BRACHIAL PLEXUS BLOCK |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
ELECTIVE ELBOW, FOREARM, WRIST AND HAND SURGERIES UNDER AXILLARY BRACHIAL PLEXUS BLOCK |
|
| ExclusionCriteria |
| Details |
ALLERGY TO DRUGS USED IN THE STUDY
HISTORY OF LONGTERM OPIOIDS OR OTHER ANALGESIC CONSUMPTIONS
PATIENTS ON SYSTEMIC CORTICOSTEROIDS FOR 2WEEKS OR MORE WITHIN 6MONTHS OF SURGERY
PATIENTS WITH BLEEDING OR COAGULATION DISORDERS
PATINETS WITH ANY NEUROLOGICAL OR MUSCULOSKELETAL DISORDERS
ANY CONTRAINDICATIONS FOR BLOCKS USED IN THE STUDY
INFECTION OF LESION AT THE SITE OF THE BLOCK
TECHNICAL FAILURE OF THE BLOCK
PREGNANT PATIENTS, PATIENTS WITH HEART BLOCK, HYPOTENSION, BRADYCARDIA, CARDIAC FAILURE |
|
|
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 FINDOUT WHETHER DEXAMETHASONE AND DEXMEDETOMIDINE WHEN COMBINED WITH 0.5% ROPIVACAINE PROLONG THE DURATION OF SENSORY AND MOTOR BLOCK |
24HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECT ON ONSET OF ACTION |
24HOURS |
| EFFECT ON POST OPERATIVE ANALGESIC REQUIREMENTS |
24HOURS |
| INCIDENCE OF BRADYCARDIA, HYPOTENSION AND ARRHYTHMIAS |
24HOURS |
| EFFECT ON PATIENT SATISFACTION |
24HOURS |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
14/09/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivananda.nadiminti@gmail.com].
- For how long will this data be available start date provided 10-09-2024 and end date provided 10-06-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
THE AIM OF THE STUDY IS TO COMPARE THE EFFICACY OF ADDING DEXAMETHASONE AND DEXMEDETOMIDINE AS ADJUVANTS TO 0.5% ROPIVACAINE IN REDUCING THE ONSET AND EXTENDING THE DURATION OF AXILLARY BLOCK AND ALSO TO COMPARE THE PAIN SCORE AND POST OPERATIVE ANALGESIC REQUIREMENT. |