N/A
Completed N=260
Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery
Pain, Postoperative
Source: ClinicalTrials.gov NCT03534063 ↗
Enrolled (actual)
260
Serious AEs
—
Results posted
Jul 2023
Primary outcomePrimary: Percentage of Patients Who Agreed to Participate — 260; 22 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Agreed to Participate |
260; 22 | — |
| PRIMARY Percentage of Participants With a Clinical Phenotype Warranting Alternative Therapy |
35; 28; 119; 46 | — |
| PRIMARY Percentage of Participants in the Genotype-guided Arm for Whom a Clinical Phenotype-guided Recommendation Was Accepted by the Clinician |
21; 101 | — |
| PRIMARY Opioid Utilization |
200; 230 | .047 sig |
| SECONDARY Composite Pain Intensity |
2.6; 2.5 | .638 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03534063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.