Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

Study Overview
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Brief Summary
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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.

Official Title
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Opioid Reduction in Orthopaedic Surgery (OREOS): A Feasibility Randomized Controlled Trial in Knee Replacement Patients

Conditions
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Knee Osteoarthritis, Chronic Post Operative Pain

Intervention / Treatment
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* Other: Multicomponent opioid reduction and pain management pathway
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 group parallel randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care group<br>This group will receive standard perioperative care, surgical treatment, and pain medications. | Other: Standard care<br>* Standard perioperative care, surgical treatment, and pain medications.<br>|
| Experimental: Opioid reduction group<br>Patients will participate in a multicomponent pathway coordinated by a trained coordinator who will facilitate patient participation and engagement with each interventional component. | Other: Multicomponent opioid reduction and pain management pathway<br>* Pre-operative pain education and expectation setting, identification and modification of risk factors in high risk patients, postoperative individualized analgesic prescriptions, and continued support for pan control and recovery facilitated by an interventions coordinator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention adherence [feasibility] | Percentage of patients receiving at least 3 of the 4 trial intervention components. | 8 weeks | 
| Participant recruitment [feasibility] | Number of participants recruited | 4 months | 
| Participant retention [feasibility] | Number of participants completing the primary outcome | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid-free pain control | 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. | 8 weeks | 
| Chronic post-surgical pain (CPSP) | Defined by the International Classification of Diseases version-11 (ICD-11) criteria | 12 months | 
| CPSP intensity of resting and movement evoked pain | Measured on a 0-10 numeric rating scale (NRS; lower score is better) | 12 months | 
| Postoperative opioid use | Presence of daily opioid use, started after surgery or increased after surgery (binary) | 12 months | 
| Satisfaction with pain control | 0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied) | 12 months | 
| Health related quality of life | EuroQol-5 Dimensions (EQ-5D) | 12 months | 
| Complications | Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, education, opioid reduction, cognitive behavioural therapy