Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000540516
Ethics application status
Approved
Date submitted
3/05/2015
Date registered
27/05/2015
Date last updated
26/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Dexamethasone in reducing pain, nausea and vomiting, improve mobilisation and reduce hospital stay in hip and knee arthroplasty: a double blind controlled trial
Scientific title
Efficacy of Dexamethasone in reducing pain, nausea and vomiting, improve mobilisation and reduce hospital stay in hip and knee arthroplasty: a double blind controlled trial
Secondary ID [1] 286631 0
Nil
Universal Trial Number (UTN)
U1111-1169-8274
Trial acronym
DexPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Arthritis 294948 0
Knee Arthritis 294949 0
Condition category
Condition code
Musculoskeletal 295210 295210 0 0
Osteoarthritis
Surgery 295211 295211 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two doses of 8mg of dexamethasone are given intravenously. The first dose is given immediately pre-operatively and the second dose given 24 hours post surgery. The syringe with the Dexamethasone will be provided to the operating room and ward by the pharmacy.
Intervention code [1] 291770 0
Treatment: Drugs
Comparator / control treatment
Placebo - Normal Saline. 10 ml are given intravenously. The first dose is given immediately pre-operatively and the second dose given 24 hours post surgery. The syringe with the Placebo will be provided to the operating room and ward by the pharmacy.
Control group
Placebo

Outcomes
Primary outcome [1] 294965 0
Length of Stay as recorded in the hospital records
Timepoint [1] 294965 0
From the time of surgery to the time of discharge
Secondary outcome [1] 314477 0
Pain Levels with Visual Analogue Score
Timepoint [1] 314477 0
Twice daily until discharge
Secondary outcome [2] 314478 0
Nausea and vomiting utilising a Visual Analogue Score
Timepoint [2] 314478 0
Twice daily until discharge.

Eligibility
Key inclusion criteria
- People who are presenting to preadmission clinic for single joint hip or knee arthroplasty.
- Able to provide informed consent
- Age 18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 or type 2 diabetes mellitus; renal failure; hepatic failure
- Use of oral corticosteroids over past 6 months
- Allergic or adverse reaction to corticosteroids in the past
- Allergy to the food preservative Sulfite (this does not include Sulpha containing medications)
- Active peptic ulcer disease with symptoms present in the previous 6 months
- Previous GIT haemorrhage
- Pregnancy and lactation
- Past history of psychotic illness (including psychotic depression)
- Current systemic fungal infection
- Administration of live vaccine in the previous 3 months
- Myasthenia gravis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified and screened at the pre-admission clinic at the Launceston General Hospital and include patients who are booked for total knee or hip arthroplasty. Pre-admission clinic occurs prior to a planned admission for elective surgery and is an opportunity for patients to be screened for conditions which may impact on their operative suitability and be prepared for surgery with the necessary pre-operative care.
Randomisation and preparation of trial drugs will be conducted by the pharmacy department at the Launceston General Hospital. The pharmacy is utilising central radomisation by computer. At the beginning of each week pharmacy will prepare randomisation packs for the number of participants who are booked for arthroplasty that week; this information will be provided to them by the research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary sample size has been calculated based on length of stay, as a key outcome for resource utilisation, and a surrogate outcome of post-operative recovery and hence immediate post-operative patient outcomes.

Using existing data which has been collected by the PI from a previous study in a similar population, in order to detect a 20% reduction in length of stay from an expected value of 6.4 days (SD 2.7) with a power of 80% a sample size of 71 is required for each group. As loss to follow up is not likely to be a significant issue in this study, we will aim for a sample size of 142.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2015
Actual
4/06/2015
Date of last participant enrolment
Anticipated
1/10/2017
Actual
1/10/2017
Date of last data collection
Anticipated
1/12/2017
Actual
1/12/2017
Sample size
Target
142
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 3742 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 5800 0
Calvary Health Care Tasmania - Launceston campus - Launceston
Recruitment postcode(s) [1] 9625 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 291203 0
Charities/Societies/Foundations
Name [1] 291203 0
Clifford Craig medical research
Country [1] 291203 0
Australia
Primary sponsor type
Individual
Name
Jonathan Mulford
Address
Tamar Orthopaedics 170 St John Street
Launceston 7250
Tasmania
Launceston General Hospital
Charles street Launceston Tasmania 7250
Country
Australia
Secondary sponsor category [1] 289883 0
None
Name [1] 289883 0
Address [1] 289883 0
Country [1] 289883 0
Other collaborator category [1] 278456 0
Individual
Name [1] 278456 0
Kathryn Ogden
Address [1] 278456 0
University Tasmania Launceston Campus
Clinical school
Launceston general hospital
Charles street
Launceston tasmania 7250
Country [1] 278456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292769 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 292769 0
Ethics committee country [1] 292769 0
Australia
Date submitted for ethics approval [1] 292769 0
23/07/2014
Approval date [1] 292769 0
12/09/2014
Ethics approval number [1] 292769 0
H0014512

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 431 431 0 0
/AnzctrAttachments/368470-Study-Protocol_Dexamethasone in Joint Replacement Surgery_Mulford_version2.docx
Attachments [2] 432 432 0 0
/AnzctrAttachments/368470-H0014512 Approval Application Letter 11.12.2014 copy.pdf

Contacts
Principal investigator
Name 56938 0
Dr Jonathan Mulford
Address 56938 0
Tamar Valley Orthopaedics
170 St John Street
Launceston
Tasmania 7250
Country 56938 0
Australia
Phone 56938 0
+61363347332
Fax 56938 0
Email 56938 0
jonathanmulford1971@gmail.com
Contact person for public queries
Name 56939 0
Jonathan Muford
Address 56939 0
Tamar Valley Orthopaedics
170 St John Street
Launceston
7250
Tasmania
Country 56939 0
Australia
Phone 56939 0
+61363347332
Fax 56939 0
Email 56939 0
jonathanmulford1971@gmail.com
Contact person for scientific queries
Name 56940 0
Jonathan Mulford
Address 56940 0
Tamar Valley Oryhopaedics
170 St John Street
Launceston
Tasmania 7250
Country 56940 0
Australia
Phone 56940 0
+61363347332
Fax 56940 0
Email 56940 0
jonathanmulford1971@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The administration of intravenous dexamethasone co... [More Details]
Study results articleYes The Journal of Arthroplasty Volume 33, Issue 11, ... [More Details]

Documents added automatically
No additional documents have been identified.