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Completed

NCT Number: NCT05414942

Opioid Reduction Program for Total Knee Replacement Patients

In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

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Key information

Conditions

Knee Injuries Disease Knee Injuries and Disorders Leg Injuries Opioid Use Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

About this study

The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.

There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older.
  • Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
  • Access to a telephone.
  • Able to consent in English.

Exclusion criteria

  • Under the age of 18.
  • Contraindications to use of opioid medication.
  • No access to a telephone.
  • Unable to understand consent materials in English.

Treatment and study plan

Opioid Reduction Program

Behavioral

Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.

Other names: TKR-ORP

Primary outcomes

  1. Opioid pills (dose and type) prescribed by Campbell Clinic.

    Time frame: 12-weeks post-op.

    transcribed from medical record at Campbell Clinic

  2. Opioid pills prescribed outside of Campbell Clinic.

    Time frame: 12-weeks post-op.

    assessed via scan of prescription drug monitoring database for Tennessee

  3. Opioid pill count questionnaire.

    Time frame: 12-weeks post-op.

    self-report from participant of how many opioids are left in the bottle at the 12 week assessment

Secondary outcomes

  1. KOOS Jr.

    Time frame: 12-weeks post-op.

    There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Campbell Clinic

Registry information

Acronym: TKR ORP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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