Health TrialsbyHealthPanel

Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

ConditionsArthritis KneeArthritis HipChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • opioid taper

    Behavioral

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

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Pharmacist-led opioid taper interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment until approximately 2 weeks after surgery

Secondary outcomes

1

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)

Time frame
From enrollment until approximately 2 weeks after surgery
2

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.

Time frame
From enrollment until approximately 2 weeks after surgery
3

Taper Efficacy

change in opioid dose from enrollment through surgery

Time frame
From enrollment until the time of surgery
4

Perioperative Pain

pain scores throughout the perioperative period

Time frame
From enrollment until approximately 2 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
Apply now