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Trial registered on ANZCTR


Registration number
ACTRN12623001070628
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
6/10/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
6/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Reduced Opioids After Total Joint Replacement Surgery (REPAIRS): A pilot randomised controlled trial
Scientific title
Feasibility of Reduced Opioids After Total Joint Replacement Surgery (REPAIRS): A pilot randomised controlled trial
Secondary ID [1] 310625 0
None
Universal Trial Number (UTN)
Trial acronym
REPAIRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip replacement surgery 331501 0
Total knee replacement surgery 331502 0
Condition category
Condition code
Musculoskeletal 328237 328237 0 0
Other muscular and skeletal disorders
Anaesthesiology 328319 328319 0 0
Pain management
Surgery 328320 328320 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reduced opioid group: Pain relief commencing upon discharge from hospital after surgery consisting of multimodal oral pain relief regimen (paracetamol 1 gram four times daily for 14 days, naproxen 500mg 12 hourly for 7 days) plus 'as needed' Oxycodone 5mgs 8 hourly up to 3 times daily (10 tablets provided).

Adherence will be monitored by patient report in a daily pain medicine diary.
Intervention code [1] 327024 0
Treatment: Drugs
Comparator / control treatment
Standard opioid group: Pain relief commencing upon discharge from hospital after surgery consisting of multimodal oral pain relief regimen (paracetamol 1 gram four times daily for 14 days, naproxen 500mg 12 hourly for 7 days) plus 'as needed' Oxycodone 5mgs 4 hourly up to 6 times daily (20 tablets provided).

Adherence will be monitored by patient report in a daily pain medicine diary.
Control group
Dose comparison

Outcomes
Primary outcome [1] 336105 0
Feasibility
Timepoint [1] 336105 0
At the conclusion of study
Primary outcome [2] 336106 0
Feasibility
Timepoint [2] 336106 0
At the conclusion of study
Primary outcome [3] 336107 0
Feasibility
Timepoint [3] 336107 0
At the conclusion of study
Secondary outcome [1] 426845 0
Acceptability
Timepoint [1] 426845 0
Quantitative - end of week 2 after discharge
Qualitative - end of week 6 after discharge for patient participants and at the completion of the study for staff participants
Secondary outcome [2] 426846 0
Pain
Timepoint [2] 426846 0
Baseline (prior to surgery e.g. at the pre-admission clinical appointment 2-6 weeks before scheduled surgery), daily for first 14 days after discharge, and end of week 6 after discharge.
Secondary outcome [3] 426847 0
Function
Timepoint [3] 426847 0
Baseline (2-6 weeks prior to surgery at the pre-admission clinic) and week 6 after discharge.
Secondary outcome [4] 426848 0
Health-related quality of life
Timepoint [4] 426848 0
Baseline (2-6 weeks prior to surgery at the pre-admission clinic), weeks 1, 2 and 6 after dischagre
Secondary outcome [5] 426849 0
Adverse events (e.g. nausea, dizziness, unsatisfactory pain management, etc)
Timepoint [5] 426849 0
Baseline (2-6 weeks prior to surgery at the pre-admission clinic), weeks 1, 2 and 6 after discharge (participants will be asked to report serious adverse events at any time, as soon as possible after the event)
Secondary outcome [6] 426850 0
Use of opioids over the last week
Timepoint [6] 426850 0
Daily for first 14 days after discharge, and end of week 6 after discharge
Secondary outcome [7] 426851 0
Use of all treatments due to their joint replacement over the last week (medications, physiotherapy, GP visits, etc)
Timepoint [7] 426851 0
End of weeks 1, 2 and 6 after discharge
Secondary outcome [8] 427192 0
Function
Timepoint [8] 427192 0
Baseline (2-6 weeks prior to surgery at the pre-admission clinic) and week 6 after discharge.

Eligibility
Key inclusion criteria
• Adult (aged 18 years and older) patients being discharged home from the acute surgical ward post unilateral total hip or knee replacement (THR / TKR) of any sex/gender.
• English proficiency required to complete questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with contraindications for opioid analgesics (e.g. history of abuse)
• Patients with contraindications for non-steroidal anti-inflammatories (NSAIDS) (e.g. renal disease, allergy, gastrointestinal or peptic ulcer disease, or cardiovascular contraindications)
• Patients with contraindications for paracetamol (e.g. liver disease, allergy)
• Patients who have a body weight of less than 50 kilograms or greater than 120 kilograms (to avoid needing to adjust the medication dose)
• Patients who have been on a regular opioids in the previous 30 days prior to screening (have taken more than 15 morphine milligram equivalents (MME) per day for more than 5 consecutive days)
• Circumstances/conditions which may interfere with the participant’s ability to give informed consent
• Patients with an American Society of Anaesthesiologists (ASA) score of 4 or above.

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)
An independent researcher will create the randomisation schedule and will provide the treatment allocations in consecutively numbered opaque envelopes, stratified by type of surgery (hip or knee replacement). Participants will be given consecutive ID numbers in the order in which they are recruited. A participant’s ID number will correspond with the next envelope in the series, which will be opened on the day of discharge and the corresponding medicine will be dispensed from the hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a computer-generated randomisation schedule using permuted blocks of 2 and 4.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Since the primary focus is to assess feasibility without formal statistical testing, we did not perform a sample size calculation. We anticipate identifying approximately 100 eligible patients over a period of 3 months. Assuming that approximately 50% will agree to participate, we will have a total sample size of 50 participants. This will give us a precision of 20 percentage points to estimate the screened-to-enrolled rate i.e. a 95% confidence interval between 0.4 and 0.5 assuming an enrolment rate of 0.5.

According to Fiore et a. (2022), the standard-deviation of pain at Day 1 after discharge is around 2.2. With 50 patients enrolled, we will be able to estimate the mean difference in pain between the two arms with a precision of 2.5 points.

Most analyses will be descriptive. We will calculate the screen-to-enrolment rate together with its 95% confidence interval. Differences in clinical patient reported outcomes (e.g. pain) between the two arms will be estimated together with 95% confidence intervals. A separate statistical analysis plan will be developed while blinded to the treatment allocation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
15/01/2024
Date of last participant enrolment
Anticipated
14/06/2024
Actual
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
50
Accrual to date
47
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25534 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41356 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314840 0
Other Collaborative groups
Name [1] 314840 0
Wiser Healthcare
Country [1] 314840 0
Australia
Funding source category [2] 314841 0
Charities/Societies/Foundations
Name [2] 314841 0
Arthritis Australia
Country [2] 314841 0
Australia
Funding source category [3] 314842 0
Other Collaborative groups
Name [3] 314842 0
ANZMUSC (Australia and New Zealand Musculoskeletal Clinical Trials Network)
Country [3] 314842 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road, Camperdown, New South Wales, 2050
Country
Australia
Secondary sponsor category [1] 316831 0
University
Name [1] 316831 0
The University of Sydney
Address [1] 316831 0
The University of Sydney NSW 2006 Australia
Country [1] 316831 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313842 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313842 0
Missenden Road, Camperdown, NSW, 2050
Ethics committee country [1] 313842 0
Australia
Date submitted for ethics approval [1] 313842 0
20/07/2023
Approval date [1] 313842 0
18/08/2023
Ethics approval number [1] 313842 0
Protocol no. X23-0219 & 2023/ETH01294

Summary
Brief summary
The REPAIRS pilot trial aims to investigate the feasibility and acceptability of a randomised controlled trial comparing a ‘standard’ regimen of opioid pain medicines to a ‘reduced’ regimen of opioid pain medicines prescribed upon discharge after total hip or knee replacement. Both groups will also receive the same robust regimen of non-opioid pain medicines. The pilot trial will be open label to prescribers and participants, however the researchers conducting the surveys and statistical analysis will be blinded to treatment allocation. We will recruit ~50 participants to test outcomes such as recruitment per screening rate, adherence to medication regimens, acceptability of surveys. There will also be an inbuilt process evaluation where we will interview all participants, and ~ 10 key staff members to qualitatively investigate the acceptability of the trial interventions and processes. Participants will be followed up for 6 weeks from hospital discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129522 0
Dr Caitlin Jones
Address 129522 0
The Institute for Musculoskeletel Health, Level 10N KGV Building, Missenden Road, Camperdown, New South Wales 2050
Country 129522 0
Australia
Phone 129522 0
+61 2 8627 6262
Fax 129522 0
Email 129522 0
caitlin.jones@sydney.edu.au
Contact person for public queries
Name 129523 0
Dr Caitlin Jones
Address 129523 0
The Institute for Musculoskeletel Health, Level 10N KGV Building, Missenden Road, Camperdown, New South Wales 2050
Country 129523 0
Australia
Phone 129523 0
+61 2 8627 6262
Fax 129523 0
Email 129523 0
caitlin.jones@sydney.edu.au
Contact person for scientific queries
Name 129524 0
Dr Caitlin Jones
Address 129524 0
The Institute for Musculoskeletel Health, Level 10N KGV Building, Missenden Road, Camperdown, New South Wales 2050
Country 129524 0
Australia
Phone 129524 0
+61 2 8627 6262
Fax 129524 0
Email 129524 0
caitlin.jones@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.