Clinical trial NCT04968132: Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees
Official title: Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Chronic Post Operative Pain
Keywords: Total knee arthroplasty
education
opioid reduction
cognitive behavioural therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: McMaster Surgical Associates
name: St. Joseph's Healthcare Foundation
First posted: 2021-07-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group parallel randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Intervention adherence [feasibility]
timeFrame: 8 weeks
measure: Participant recruitment [feasibility]
timeFrame: 4 months
measure: Participant retention [feasibility]
timeFrame: 8 weeks
Secondary outcomes:
measure: Opioid-free pain control
timeFrame: 8 weeks
measure: Chronic post-surgical pain (CPSP)
timeFrame: 12 months
measure: CPSP intensity of resting and movement evoked pain
timeFrame: 12 months
measure: Postoperative opioid use
timeFrame: 12 months
measure: Satisfaction with pain control
timeFrame: 12 months
measure: Health related quality of life
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
Other outcomes:
measure: Health economics
timeFrame: 12 months
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Harsha Shanthanna, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madden K, Pallapothu S, Young Shing D, Adili A, Bhandari M, Carlesso L, Khan M, Kleinlugtenbelt YV, Krsmanovic A, Nowakowski M, Packham T, Romeril E, Tarride JE, Thabane L, Tushinski DM, Wallace C, Winemaker M, Shanthanna H. Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty. Pilot Feasibility Stud. 2024 Feb 15;10(1):30. doi: 10.1186/s40814-024-01457-9.