Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees (OREOS)

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

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Chronic Post Operative Pain
• Intervention / Treatment: Other: Standard care; Other: Multicomponent opioid reduction and pain management pathway

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care group; This group will receive standard perioperative care, surgical treatment, and pain medications.	Other: Standard care; Standard perioperative care, surgical treatment, and pain medications.
Experimental: Opioid reduction group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid-free pain control	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.	8 weeks
Chronic post-surgical pain (CPSP)	Defined by the International Classification of Diseases version-11 (ICD-11) criteria	12 months
CPSP intensity of resting and movement evoked pain	Measured on a 0-10 numeric rating scale (NRS; lower score is better)	12 months
Postoperative opioid use	Presence of daily opioid use, started after surgery or increased after surgery (binary)	12 months
Satisfaction with pain control	0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)	12 months
Health related quality of life	EuroQol-5 Dimensions (EQ-5D)	12 months
Complications	Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economics	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	12 months

Collaborators and Investigators

• Sponsor: Kim Madden
• Collaborators: St. Joseph's Healthcare Hamilton; McMaster Surgical Associates; St. Joseph's Healthcare Foundation
• Investigators: Principal Investigator: Harsha Shanthanna, MD PhD FRCPC, McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): July 14, 2024
• Study Completion (Actual): July 14, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; education; cognitive behavioural therapy; opioid reduction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: OREOS-knee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No