Opioid Reduction Program for Total Knee Replacement Patients

Not Applicable

Completed

• Conditions: Knee Injuries; Knee Injuries and Disorders; Opioid Use
• Interventions: Behavioral: Opioid Reduction Program

• Registration Number: NCT05414942
• Lead Sponsor: University of Tennessee

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Reduction Program	Opioid Reduction Program	Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery.

Primary Outcome Measures

Name	Time	Method
Opioid pills (dose and type) prescribed by Campbell Clinic.	12-weeks post-op.	transcribed from medical record at Campbell Clinic
Opioid pill count questionnaire.	12-weeks post-op.	self-report from participant of how many opioids are left in the bottle at the 12 week assessment
Opioid pills prescribed outside of Campbell Clinic.	12-weeks post-op.	assessed via scan of prescription drug monitoring database for Tennessee

Secondary Outcome Measures

Name	Time	Method
KOOS Jr.	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

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States