None listed
Conditions
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.
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 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.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed