None listed
Conditions
Brief summary
Many people are given opioid medications such as oxycodone after hip or knee replacement surgery to help manage pain. While these medications can be effective for short-term relief, they come with serious risks, particularly when use continues beyond the recovery period. Ongoing opioid use after surgery has been linked to falls, fractures, constipation, higher infection rates, and even the need for revision surgery. Yet, inappropriate persistent use of opioids after hip or knee arthroplasty remains common in Australia and around the world. Tapentadol is a newer opioid that may offer similar pain relief to oxycodone but with fewer side effects. Early research suggests that patients taking tapentadol may be less likely to continue using opioids long-term. However, these findings come from observational studies, and more rigorous evidence is needed to confirm whether this alternative truly reduces the risk of persistent opioid use. This pilot study will compare tapentadol and oxycodone in patients recovering from hip or knee replacement surgery. Participants will be randomly assigned to receive either tapentadol or oxycodone as needed for pain, while all other aspects of post-operative care including non-opioid medications and anaesthetic techniques will remain the same between groups. The study will take place across multiple hospitals in Australia and include both metropolitan and regional sites. The main goal of the study is to see whether it is feasible to run a larger trial by looking at how many eligible patients can be recruited, how many stay in the study, and how closely they follow their assigned treatment. The study will also explore whether patients taking tapentadol are less likely to continue using opioids 90 days after surgery, and whether they report less pain, and improved function. Safety outcomes, including opioid-related side effects during the hospital stay and after discharge, will also be closely monitored. By testing whether an alternative opioid can reduce the risk of long-term harms, this study has the potential to improve surgical recovery and reshape how post-operative pain is managed in Australia.
Interventions
This will be a randomised controlled pilot study.
The intervention arm will be tapentadol immediate release (IR) oral plus usual care post total hip or knee arthroplasty once patient is tolerating oral medications. Tapentadol will be used as needed for pain.
Dosage and duration will be guided by the product information and adjusted according to individual pain response and clinical judgement. Maximum dose is 600mg in 24 hours. During admission, nursing staff will administer medications for pati
This will be a randomised controlled pilot study. The intervention arm will be tapentadol immediate release (IR) oral plus usual care post total hip or knee arthroplasty once patient is tolerating oral medications. Tapentadol will be used as needed for pain. Dosage and duration will be guided by the product information and adjusted according to individual pain response and clinical judgement. Maximum dose is 600mg in 24 hours. During admission, nursing staff will administer medications for patients. Usual care will be determined by each individual hospital processes, but may include paracetamol and non-steroidal anti-inflammatory medications.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older, is planned to receive elective unilateral or bilateral total hip or knee arthroplasty, speaks and reads English and has access to internet or a telephone.
Exclusion criteria
Planned repeat surgeries (same procedure within 6 months), major cognitive impairment, using opioids for cancer, palliative care or substance use disorder, medical conditions contraindicating the use of tapentadol or oxycodone, opioid hypersensitivity, taking medications which are contraindicated for use with oxycodone or tapentadol
Outcome results
None listed