Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

Sponsor
Kim Madden (Other)
Overall Status
Recruiting
CT.gov ID
NCT04968132
Collaborator
St. Joseph's Healthcare Hamilton (Other), McMaster Surgical Associates (Other), St. Joseph's Healthcare Foundation (Other)
100
1
2
23.8
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multicomponent opioid reduction and pain management pathway
  • Other: Standard care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 group parallel randomized controlled trial2 group parallel randomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Opioid Reduction in Orthopaedic Surgery (OREOS): A Feasibility Randomized Controlled Trial in Knee Replacement Patients
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Intervention adherence [feasibility] [8 weeks]

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

  2. Participant recruitment [feasibility] [4 months]

    Number of participants recruited

  3. Participant retention [feasibility] [8 weeks]

    Number of participants completing the primary outcome

Secondary Outcome Measures

  1. Opioid-free pain control [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) [12 months]

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

  3. CPSP intensity of resting and movement evoked pain [12 months]

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

  4. Postoperative opioid use [12 months]

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

  5. Satisfaction with pain control [12 months]

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

  6. Health related quality of life [12 months]

    EuroQol-5 Dimensions (EQ-5D)

  7. Complications [12 months]

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

Other Outcome Measures

  1. Health economics [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N 4A6

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Harsha Shanthanna, MD PhD FRCPC, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kim Madden, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier:
NCT04968132
Other Study ID Numbers:
  • OREOS-knee
First Posted:
Jul 20, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kim Madden, Assistant Professor, McMaster University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022