Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788016
• Other study ID #: IRB-300009887
• Secondary ID: 1K23AR080224-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: March 3, 2025

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Kevin R Riggs, MD
• Phone: 205-934-0778
• Email: kriggs[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 3, 2025
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis Hip
• Arthritis Knee
• Chronic Pain

Intervention

Behavioral:
• opioid taper
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period

Locations

Country	Name	City	State
United States	UAB Hospital-Highlands	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	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.	From enrollment until approximately 2 weeks after surgery
Secondary	Study Recruitment Rate	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)	From enrollment until approximately 2 weeks after surgery
Secondary	Study Retention Rate	In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.	From enrollment until approximately 2 weeks after surgery
Secondary	Taper Efficacy	change in opioid dose from enrollment through surgery	From enrollment until the time of surgery
Secondary	Perioperative Pain	pain scores throughout the perioperative period	From enrollment until approximately 2 weeks after surgery