| CTRI Number |
CTRI/2019/04/018538 [Registered on: 10/04/2019] Trial Registered Prospectively |
| Last Modified On: |
11/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of 2 doses of dexamethasone as addition to bupivacaine for brachial plexus block in patients undergoing upper limb surgery. |
Scientific Title of Study
Modification(s)
|
Comparison of Dexamethasone 4mg and 8mg as an Adjuvant to 0.5% Bupivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgeries-A Randomised Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun BK |
| Designation |
Senior Resident |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,VV PURAM ,KR ROAD ,BENGALURU .
Bangalore
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun BK |
| Designation |
Senior Resident |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,VV PURAM ,KR ROAD ,BENGALURU .
Bangalore
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun BK |
| Designation |
Senior Resident |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES,VV PURAM ,KR ROAD ,BENGALURU .
Bangalore
KARNATAKA
560004
India |
| Phone |
9972802569 |
| Fax |
|
| Email |
arjun.bg88@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.LAVANYA CHETAN,POST GRADUATE ,KIMS, BANGALORE |
|
|
Primary Sponsor
|
| Name |
Dr LAVANYA CHETAN |
| Address |
POST GRADUATE KIMS BANGALORE |
| 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 |
| DRLAVANYA CHETAN |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
OPERATION ROOM,A BLOCK 4TH FLOOR,DEPARTMENT OF ANAESTHESIOLOGY,VV PURAM,KR ROAD,BENGALURU KARNATAKA
Bangalore
KARNATAKA |
9663544224
doclavanyachetan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W011||Fall on same level from slipping,tripping and stumbling with subsequent striking against object, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1
|
1.DEXAMETHASONE 4 mg AS AN ADJUVANT TO 0.5% BUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK.
|
| Comparator Agent |
GROUP 2 |
DEXAMETHASONE 8mg AS AN ADJUVANT TO 0.5% BUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGISTS(ASA) 1AND 2.
PATIENT UNDERGOING ELECTIVE UPPER LIMB SURGERIES UNDER SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK. |
|
| ExclusionCriteria |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGISTS(ASA) 3 AND MORE.
PATIENT WITH RENAL AND HEPATIC FAILURE,NEUROMUSCULAR AND CARDIOVASCULAR DISEASE.
PATIENT WITH PREGNANCY AND HYPERSENSITIVITY TO STUDY DRUG |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION FOR REQUEST OF FIRST RESCUE ANALGESIA |
number of doses of analgesia required |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PATIENT SATISFACTION
TOTAL ANALGESIC REQUIREMENT IN FIRST 24 HOURS |
UP TO 24 HOURS |
|
|
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
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
15/04/2019 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.K. C. Cummings, D. E. Napierkowski, I. Parra-Sanchez, A. Kurz, J. E. Dalton, J. J. Brems, D. I. Sessler; Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine, BJA: British Journal of Anaesthesia, Volume 107, Issue 3, 1 September 2011, Pages 446–453, https://doi.org/10.1093/bja/aer159.2.Biradar PA, Kaimar P, Gopalakrishna K. Effect of dexamethasone added to lidocaine in supraclavicular brachial plexus block: A prospective, randomised, double-blind study. Indian J Anaesth. 2013;57(2):180-4. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Local anesthetics alone for Supraclavicular brachial plexus block provide good operative conditions but have shorter duration of postoperative analgesia. Dexamethasone is a very potent and highly selective glucocorticoid. Various studies have been done using dexamethasone as an adjuvant to local anesthetics mixture in brachial plexus block resulting in variable effects on onset but prolonged duration of analgesia and motor block. This study attempts to compare the two doses of dexamethasone for onset time and duration of sensory and motor block. |