Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees
- Conditions
- Knee OsteoarthritisChronic Post Operative Pain
- Interventions
- Other: Multicomponent opioid reduction and pain management pathwayOther: Standard care
- Registration Number
- NCT04968132
- Lead Sponsor
- Kim Madden
- Brief Summary
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.
People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.
This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Adult (18+)
- Undergoing elective total knee arthroplasty (TKA) for knee arthritis
- Can use a simple electronic (phone or tablet) device
- Provide informed consent to participate
- Revision surgery
- Simultaneous bilateral arthroplasties
- Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid reduction group Multicomponent opioid reduction and pain management pathway Patients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component. Standard care group Standard care This group will receive standard perioperative care, surgical treatment, and pain medications.
- Primary Outcome Measures
Name Time Method Participant recruitment [feasibility] 4 months Number of participants recruited
Participant retention [feasibility] 8 weeks Number of participants completing the primary outcome
Intervention adherence [feasibility] 8 weeks Percentage of patients receiving at least 3 of the 4 trial intervention components.
- Secondary Outcome Measures
Name Time Method CPSP intensity of resting and movement evoked pain 12 months Measured on a 0-10 numeric rating scale (NRS; lower score is better)
Postoperative opioid use 12 months Presence of daily opioid use, started after surgery or increased after surgery (binary)
Satisfaction with pain control 12 months 0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)
Health related quality of life 12 months EuroQol-5 Dimensions (EQ-5D)
Chronic post-surgical pain (CPSP) 12 months Defined by the International Classification of Diseases version-11 (ICD-11) criteria
Opioid-free pain control 8 weeks Three or more consecutive days of \<4/10 pain score on a 0-10 numeric rating scale (NRS; lower score is better) with no opioid use for the operated knee.
Complications 12 months Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions
Trial Locations
- Locations (1)
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada