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OpenTrials
Completed

NCT Number: NCT04968132

Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multicomponent opioid reduction and pain management pathway

Other

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.

Standard care

Other

Standard perioperative care, surgical treatment, and pain medications.

Primary outcomes

  1. Intervention adherence [feasibility]

    Time frame: 8 weeks

    Percentage of patients receiving at least 3 of the 4 trial intervention components.

  2. Participant recruitment [feasibility]

    Time frame: 4 months

    Number of participants recruited

  3. Participant retention [feasibility]

    Time frame: 8 weeks

    Number of participants completing the primary outcome

Secondary outcomes

  1. Opioid-free pain control

    Time frame: 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.

  2. Chronic post-surgical pain (CPSP)

    Time frame: 12 months

    Defined by the International Classification of Diseases version-11 (ICD-11) criteria

  3. CPSP intensity of resting and movement evoked pain

    Time frame: 12 months

    Measured on a 0-10 numeric rating scale (NRS; lower score is better)

  4. Postoperative opioid use

    Time frame: 12 months

    Presence of daily opioid use, started after surgery or increased after surgery (binary)

  5. Satisfaction with pain control

    Time frame: 12 months

    0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)

  6. Health related quality of life

    Time frame: 12 months

    EuroQol-5 Dimensions (EQ-5D)

  7. Complications

    Time frame: 12 months

    Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions

Other outcomes

  1. Health economics

    Time frame: 12 months

    Investigators will use the EQ-5D to assess health utilities for the purpose of health economic analyses (e.g., cost-effectiveness). Intervention costs and healthcare resource utilization information (e.g., hospitalization, physician visits) as well as information on productivity (e.g., time missed from work) will be collected using a self-administered questionnaire, which will be developed for the purpose of this study

Sponsors and collaborators

Lead sponsor

Kim Madden

Other

Collaborators

  • McMaster Surgical Associates
  • St. Joseph's Healthcare Foundation
  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Acronym: OREOS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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