Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

NCT04968132 | Completed

• 1 other identifier: OREOS-knee
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Chronic Post Operative Pain

Keywords

Total knee arthroplasty; education; opioid reduction; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Other Outcomes (1)

• Health economics

  12 months

Study Arms (2)

Standard care group

ACTIVE COMPARATOR

This group will receive standard perioperative care, surgical treatment, and pain medications.

Other: Standard care

Opioid reduction group

EXPERIMENTAL

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

Interventions

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.

Opioid reduction group

Standard care OTHER

Standard perioperative care, surgical treatment, and pain medications.

Standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Revision surgery
• Simultaneous bilateral arthroplasties
• Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)

Sponsors & Collaborators

• Kim Madden: lead
• St. Joseph's Healthcare Hamilton: collaborator
• McMaster Surgical Associates: collaborator
• St. Joseph's Healthcare Foundation: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 38360686 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Harsha Shanthanna, MD PhD FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2 group parallel randomized controlled trial

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: March 9, 2022
• Primary Completion: July 14, 2024
• Study Completion: July 14, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CA (1)