Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Participant recruitment [feasibility]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the nature of the study interventions, patients and the health care team cannot be blinded. An independent blinded surgeon will evaluate each adverse event to minimize the risk of bias for that outcome. The primary study outcome of non-opioid pain control will be collected using a daily e-diary up to 8 weeks. Other study outcomes will be collected by a research personnel not involved in the clinical care. Data analysts will be blinded for all outcomes
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Revision surgery
- •Simultaneous bilateral arthroplasties
- •Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
Outcomes
Primary Outcomes
Participant recruitment [feasibility]
Time Frame: 4 months
Number of participants recruited
Participant retention [feasibility]
Time Frame: 8 weeks
Number of participants completing the primary outcome
Intervention adherence [feasibility]
Time Frame: 8 weeks
Percentage of patients receiving at least 3 of the 4 trial intervention components.
Secondary Outcomes
- Opioid-free pain control(8 weeks)
- Chronic post-surgical pain (CPSP)(12 months)
- CPSP intensity of resting and movement evoked pain(12 months)
- Postoperative opioid use(12 months)
- Satisfaction with pain control(12 months)
- Health related quality of life(12 months)
- Complications(12 months)
Investigators
Kim Madden
Assistant Professor
McMaster University