CTRI Number |
CTRI/2021/02/031293 [Registered on: 15/02/2021] Trial Registered Prospectively |
Last Modified On: |
13/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical comparison between a local anaesthetic and local anaesthetic with steroid combination in ultra sonography guided supraclavicular block |
Scientific Title of Study
|
A clinical comparison between 0.5% levobupivacaine and 0.5% levobupivacaine with dexamethasone 8mg combination under USG guided brachial plexus block by supraclavicular approach |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anusha G Hiremath |
Designation |
Junior Resident |
Affiliation |
Vijayanagar Institute of Medical Sciences |
Address |
Department of anaesthesiology
Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104
Karnataka
India
Bellary KARNATAKA 534104 India |
Phone |
8073830052 |
Fax |
|
Email |
anushavidya1@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anusha G Hiremath |
Designation |
Junior Resident |
Affiliation |
Vijayanagar Institute of Medical Sciences |
Address |
Department of anaesthesiology
Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104
Karnataka
India
Bellary KARNATAKA 534104 India |
Phone |
8073830052 |
Fax |
|
Email |
anushavidya1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr B Devanand |
Designation |
Professor and HOD |
Affiliation |
Vijayanagar Institute of Medical Sciences |
Address |
Department of anaesthesiology
Vijayanagar Institute of Medical Sciences, Cantontment, Ballari-583104
Karnataka
India
Bellary KARNATAKA 583104 India |
Phone |
9845233239 |
Fax |
|
Email |
dr.devanand.b@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
Vijayanagar Institute of medical sciences Ballari |
|
Primary Sponsor
|
Name |
Vijayanagar Institute of Medical Sciences |
Address |
Cantontment, Ballari-583104 |
Type of Sponsor |
Government medical college |
|
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 Anusha G Hiremath |
Vijayanagar Institute Of Medical Sciences |
Department of anaesthesiology, Major OT complex, VIMS Cantontment, Ballari Bellary KARNATAKA |
8073830052
anushavidya1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Vijayanagar Institute Of Medical Sciences Ethics Committee |
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 |
Intervention |
0.5 % LEVOBUPIVACAINE with DEXAMETHASONE 8mg |
0.5% LEVOBUPIVACAINE(25ml) + 2ml DEXAMETHASONE (8mg)
Dose- 27ml
IV administration
Frequency- once
Duration of therapy- rescue analgesic ( inj.tramadol 100mg IV) will be given once pain score is equal or more than 5 based on NRS
|
Comparator Agent |
0.5% LEVOBUPIVACAINE |
0.5% LEVOBUPIVACAINE (25ml)
+ 2ml NS(0.9%)
Dose- 27ml
IV administration
Frequency- once
Duration of therapy- rescue analgesic ( inj.tramadol 100mg IV) will be given once pain score is equal or more than 5 based on NRS |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients with ASA class 1 & 2 |
|
ExclusionCriteria |
Details |
a)Refusal by patients for the block or study.
b)Patients with abnormal BT,CT or on anticoagulation therapy, severe anaemia ,hypovolemia ,shock ,septicaemia and h/o seizures.
c)Local infection at the site of puncture.
d)Allergy to the study drugs.
e)History of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system.
f)Patients who are not co-operative and require additional sedatives.
|
|
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 know the effect of dexamethasone 8mg with 0.5% levobupivacaine on the duration of post-operative analgesia in ultrasound guided supraclavicular brachial plexus block. |
Baseline, 0 min( immediately after drug administration), 1min, 3min,5min, 7min, 10min, 15min,20min, 25min, 30min,45min, 60min,90min, 120min,3hr, 4hr,6hr,12hr,24hr |
|
Secondary Outcome
|
Outcome |
TimePoints |
a)the onset of sensory and motor blockade.
b)the duration of sensory and motor blockade.
c)hemodynamic variables (HR, BP, O2 saturation).
d)time for first rescue analgesia.
e)total dose of rescue analgesia in 24hrs.
|
Upto 24hrs after giving the block |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
18/02/2021 |
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
|
Brachial plexus block is a popular and widely employed regional nerve block technique for anaesthesia and postoperative analgesia for surgeries of the upper extremities. Dexamethasone is a very potent and highly selective glucocorticoid used as anti-inflammatory and immunosuppressant. Steroids have anti-inflammatory as well as analgesic effects. Many studies have successfully proved the usefulness of dexamethasone as an effective analgesic. This study is designed to know the beneficial effects of addition of dexamethasone to a local anaesthetic in ultra sound guided brachial plexus block by supraclavicular approach. |