Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Not Applicable

Recruiting

• Conditions: Chronic Pain; Arthritis Knee; Arthritis Hip
• Interventions: Behavioral: opioid taper

• Registration Number: NCT05788016
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2024-01-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacist-led opioid taper intervention	opioid taper	The participant will attempt to taper their opioid dose by \~50% during the 4-6 week 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.

Primary Outcome Measures

Name	Time	Method
Acceptability	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 Outcome Measures

Name	Time	Method
Study Retention Rate	From enrollment until approximately 2 weeks after surgery	In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.
Perioperative Pain	From enrollment until approximately 2 weeks after surgery	pain scores throughout the perioperative period
Taper Efficacy	From enrollment until the time of surgery	change in opioid dose from enrollment through surgery
Study Recruitment Rate	From enrollment until approximately 2 weeks after surgery	In order to assess feasibility of the taper intervention, we will track the proportion of participants who are offered enrollment that ultimately enroll (will be measured separately for those offered enrollment in person and those who are mailed information about the study)

Trial Locations

Locations (1)

UAB Hospital-Highlands; 🇺🇸 Birmingham, Alabama, United States