RecruitingPhase 4ACTRN12623001070628

Reduced Opioids After Total Joint Replacement Surgery (REPAIRS): A pilot randomised controlled trial

Feasibility of Reduced Opioids After Total Joint Replacement Surgery (REPAIRS): A pilot randomised controlled trial


Sponsor

Royal Prince Alfred Hospital

Enrollment

50 participants

Start Date

Jan 15, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Hip and knee replacement surgery is one of the most commonly performed and successful orthopaedic procedures, but recovery involves real pain — and opioid pain medications are often prescribed to manage it. There is growing recognition that many patients may not need as many opioids as are routinely prescribed, and that reducing opioid use after surgery can lower the risk of dependence and other side effects. The REPAIRS pilot trial tests whether a reduced opioid regimen is just as effective as the standard approach. About 50 patients going home after hip or knee replacement will be randomly assigned to either a standard or a reduced opioid prescription, with both groups also receiving a full non-opioid pain management regimen. Researchers will track pain levels, medication use, and patient satisfaction over six weeks. All participants and some key staff will also be interviewed about their experience of the study. You may be eligible if you are 18 or older, are being discharged home after a total hip or knee replacement, and do not have a history of opioid use or contraindications to common pain medications. The pilot trial is run by Royal Prince Alfred Hospital.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 500

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.


Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12623001070628