Skip to main content
Clinical Trials/NCT05788016
NCT05788016
Recruiting
Not Applicable

Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development

University of Alabama at Birmingham1 site in 1 country45 target enrollmentJanuary 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis Knee
Sponsor
University of Alabama at Birmingham
Enrollment
45
Locations
1
Primary Endpoint
Acceptability
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:

  • Is the intervention feasible and acceptable to patients?
  • Does the intervention result in a decrease in opioid dose during the preoperative period?

Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.

Registry
clinicaltrials.gov
Start Date
January 10, 2024
End Date
September 1, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Riggs

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
  • currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
  • have a reliable telephone number for contact
  • speaks English

Exclusion Criteria

  • Taking opioid medications that include:
  • Buprenorphine
  • Methadone
  • Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
  • Transdermal formations of opioid pain medications (e.g., fentanyl patches)

Outcomes

Primary Outcomes

Acceptability

Time Frame: From enrollment until approximately 2 weeks after surgery

Mixed-methods assessment of the intervention by participants. Participants will provide qualitative feedback at multiple points during and after the intervention, and will quantitatively rate satisfaction at the end of the study. These results will be analyzed jointly to determine acceptability.

Secondary Outcomes

  • Study Retention Rate(From enrollment until approximately 2 weeks after surgery)
  • Perioperative Pain(From enrollment until approximately 2 weeks after surgery)
  • Taper Efficacy(From enrollment until the time of surgery)
  • Study Recruitment Rate(From enrollment until approximately 2 weeks after surgery)

Study Sites (1)

Loading locations...

Similar Trials