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Clinical Trials/NCT04968132
NCT04968132CompletedNot Applicable

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

Kim Madden2 sites in 1 country102 target enrollmentStarted: March 9, 2022Last updated:
Conditions

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

Sponsor
Kim Madden
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Kim Madden

Assistant Professor

McMaster University

Study Sites (2)

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