Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

Knee Osteoarthritis Clinical Trial

— OREOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04968132
• Other study ID #: OREOS-knee
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Pain, Postoperative

Intervention

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.
• Standard care
Standard perioperative care, surgical treatment, and pain medications.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Kim Madden	McMaster Surgical Associates, St. Joseph's Healthcare Foundation, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Intervention adherence [feasibility]	Percentage of patients receiving at least 3 of the 4 trial intervention components.	8 weeks
Primary	Participant recruitment [feasibility]	Number of participants recruited	4 months
Primary	Participant retention [feasibility]	Number of participants completing the primary outcome	8 weeks
Secondary	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
Secondary	Chronic post-surgical pain (CPSP)	Defined by the International Classification of Diseases version-11 (ICD-11) criteria	12 months
Secondary	CPSP intensity of resting and movement evoked pain	Measured on a 0-10 numeric rating scale (NRS; lower score is better)	12 months
Secondary	Postoperative opioid use	Presence of daily opioid use, started after surgery or increased after surgery (binary)	12 months
Secondary	Satisfaction with pain control	0 to 100 scale (0=extremely dissatisfied, 100=extremely satisfied)	12 months
Secondary	Health related quality of life	EuroQol-5 Dimensions (EQ-5D)	12 months
Secondary	Complications	Surgery-related and knee-related adverse events, pain medication related adverse events, and readmissions	12 months