Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Chronic Post Operative Pain

• 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

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-20
• Study Start: 2022-03-09
• Primary Completion: 2024-07-14
• Study Completion: 2024-07-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada