Opioid Reduction Program for Total Knee Replacement Patients

NCT05414942 | Completed

• 1 other identifier: 21-08206-XP
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Knee Injuries and Disorders; Opioid Use

Keywords

Opioid; Total Knee Replacement; Knee Arthroplasty; Knee Injuries; Prevention; Analgesics, Opioid

Outcome Measures

Primary Outcomes (3)

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

  transcribed from medical record at Campbell Clinic

  12-weeks post-op.

• Opioid pills prescribed outside of Campbell Clinic.

  assessed via scan of prescription drug monitoring database for Tennessee

  12-weeks post-op.

• Opioid pill count questionnaire.

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

  12-weeks post-op.

Secondary Outcomes (1)

• KOOS Jr.

  12-weeks post-op.

Study Arms (2)

Treatment As Usual (TAU)

NO INTERVENTION

No intervention will be administered.

Opioid Reduction Program

EXPERIMENTAL

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

Behavioral: Opioid Reduction Program

Interventions

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.

Also known as: TKR-ORP

Opioid Reduction Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead
• Campbell Clinic: collaborator

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Knee Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Derefinko, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 10, 2022
• Study Start: August 1, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years after data collection ends

Locations

US (1)