| CTRI Number |
CTRI/2023/02/050033 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
THIS STUDY IS TO COMPARE DIFFERENT DRUGS , DEXAMETHASONE(8MG) VERSUS DEXMEDETOMIDINE(50MCG) IN ADDITION TO COMBINATION OF 0.5% ROPIVACAINE AND 0.5% BUPIVACAINE USED IN UPPER LIMB BLOCKS USING ULTRASOUND FOR UPPER LIMB SURGERIES |
|
Scientific Title of Study
|
A CLINICAL COMPARISON BETWEEN PERINEURAL DEXAMETHASONE(8MG) AND DEXMEDETOMIDINE(50MCG) AS AN ADJUVANT TO COMBINATION OF 0.5% ROPIVACAINE AND 0.5% BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayanand S |
| Designation |
Professor |
| Affiliation |
Kims hospital |
| Address |
Department of Anaesthesiology Kempegowda institute of medical sciences
K R road
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
dr.vanand@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayanand S |
| Designation |
Professor |
| Affiliation |
Kims hospital |
| Address |
Department of Anaesthesia Kempegowda institute of medical sciences
K R road
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
dr.vanand@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayanand S |
| Designation |
Professor |
| Affiliation |
Kims hospital |
| Address |
Department of anaesthesia Kempegowda institute of medical sciences
K R road
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9341231411 |
| Fax |
|
| Email |
dr.vanand@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
Krishna Rajendra Rd, Parvathipuram, Vishweshwarapura, Shankarapura, Bengaluru, Karnataka 560002 |
| 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 |
| Ajay kumar |
kims hospital |
Department of Anaesthesia
Kim’s hospital
k r road , v v Puram ,bangalore-560002
Bangalore
KARNATAKA |
9738138140
anajay1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine(50mcg), 10ml of 0.5% ropivacaine , 10ml of 0.5% bupivacaine |
Dexmedetomidine(50mcg), 10ml of 0.5% ropivacaine , 10ml of 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block before starting the procedure for upper limb surgeries( duration- patient will be observed 24hrs from start of procedure). All above drugs are given only once before starting the procedure and observed for onset and duration of the block given. |
| Intervention |
DEXMETHASONE 8MG ,10 ML OF 0.5% ROPIVACAINE,10ML OF 0.5% BUPIVACAINE |
DEXMETHASONE 8MG ,10 ML OF 0.5% ROPIVACAINE,10ML OF 0.5% BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK BEFORE STARTING THE PROCEDURE FOR UPPER LIMB SURGERIES (Duration-Patient will be observed for 24hrs ) . All above drugs are given only once before starting the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2
BODY WEIGHT 50-80KGS |
|
| ExclusionCriteria |
| Details |
SEPSIS AT SITEOF INFECTION
PATIENTS NOTWILLING TO GIVE INFORMED CONSENT
PATIENTS WITH NEUROLOGICAL DEFICITS INVOLVING BRACHIAL PLEXUS.
COAGULOPATHY
KNOWN HYPERSENSITIVITY TO LOCAL ANAESTHETICS
PREGNANCY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| monitoring analgesia for period of 24hrs |
monitoring analgesia for period of 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of postoperative analgesia |
24hrs |
|
|
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)
|
01/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
comparison between perineural dexamethasone(8mg) and dexmedetomidine(50mcg) as an adjuvant to combination of 0.5% Ropivacaine and 0.5% Bupivacaine in ultrasound guided supraclavicular brachial plexus block for upper limb surgeries. Aim is to find the onset and duration of sensory and motor block and duration of postoperative analgesia |