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Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

NCT ID: NCT04968132

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2024-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis Chronic Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 group parallel randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Standard care group

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

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard perioperative care, surgical treatment, and pain medications.

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.

Group Type EXPERIMENTAL

Multicomponent opioid reduction and pain management pathway

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Standard care

Standard perioperative care, surgical treatment, and pain medications.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster Surgical Associates

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Foundation

OTHER

Sponsor Role collaborator

Kim Madden

OTHER

Sponsor Role lead

Responsible Party

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Kim Madden

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Harsha Shanthanna, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 38360686 (View on PubMed)

Other Identifiers

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OREOS-knee

Identifier Type: -

Identifier Source: org_study_id