Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: opioid taper.
- Who it may be relevant to
- Registry conditions: Arthritis Knee, Arthritis Hip, Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development
Overview
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.
Interventions
- Behavioral opioid taper
The participant will attempt to taper their opioid dose by \~50% during the 4-6 week preoperative period
Primary outcome measures
- Acceptability [Time frame: From enrollment until approximately 2 weeks after surgery]
Secondary outcome measures (4)
- Study Recruitment Rate [Time frame: From enrollment until approximately 2 weeks after surgery]
- Study Retention Rate [Time frame: From enrollment until approximately 2 weeks after surgery]
- Taper Efficacy [Time frame: From enrollment until the time of surgery]
- Perioperative Pain [Time frame: From enrollment until approximately 2 weeks after surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UAB Hospital-Highlands — Birmingham
Identifiers
NCT: NCT05788016 · IRB-300009887 · 1K23AR080224-01A1