Opioid Reduction Program for Total Knee Replacement Patients (TKR ORP)

University of Tennessee

Status: Completed

Conditions: Knee Injuries; Knee Injuries and Disorders; Opioid Use

Treatments: Behavioral: Opioid Reduction Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05414942

21-08206-XP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

85 participants in 2 patient groups

Treatment As Usual (TAU)

No Intervention group

Description:

No intervention will be administered.

Opioid Reduction Program

Experimental group

Description:

Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery.

Treatment:

Behavioral: Opioid Reduction Program