Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery

Completed · Not applicable

Conditions studied: Pain, Postoperative

In brief

This will be a randomized, open-labeled pilot pragmatic clinical trial. Patients undergoing arthroplasty surgery will be recruited from the University of Florida (UF) Health Gainesville and the Villages Orthopedic clinics for CYP2D6 pharmacogenetic testing to manage post-surgical pain. Patients will be randomized 2:1 to either usual care or genotype-guided care. The aims of the study were to: 1) test the feasibility of a genotype-guided opioid prescribing approach for patients undergoing an outpatient surgical procedure, a group at high risk for persistent opioid use; and 2) evaluate the effect of genotype-guided post-surgical pain management on pain control and opioid prescribing.

Key facts

Study ID

NCT03534063

Run by

University of Florida

People needed

260

Starts

2018-06-07

Expected to finish

2020-04-29

Last updated by the study team

2023-07-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo total joint arthroplasty at area hospital
• Primary unilateral total hip or knee arthroplasty scheduled within approximately 6 months of the initial evaluation clinic visit

You may not qualify if…

• Patients scheduled to undergo a revision or bilateral procedure
• Receiving chronic opioid therapy, defined as the use of opioids on most days for > 3 month
• Allergy to opioids

Where it is running

• UF Health at the University of Florida — Gainesville, Florida, United States
• Unversity of Florida — Gainesville, Florida, United States
• UF Health Orthopaedic--Villages — Summerfield, Florida, United States

Full record on ClinicalTrials.gov

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