At a glance
ClinicalIndex Comparison Record- ✓Assigned female at birth, aged 18 years or older
- ✓Major gynecologic surgery planned (hysterectomy, myomectomy, exploratory laparotomy, open abdominal surgery)
- ✓Willing to provide buccal swab for pharmacogenetic testing
- ✕Chronic opioid therapy (≥3 consecutive months of monthly opioid prescriptions)
- ✕Pregnancy
- ✕Breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacogenetic-guided Choice of Post-surgery Analgesics
In Brief
A clinical study evaluating Pharmacogenetic testing, Pharmacist note with genotype-guided analgesic recommendations, and 1 other intervention for Acute Pain and Post Operative Pain. Completed, enrolled 112 participants across 1 site.
Detailed Summary
Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects or therapeutic failure from analgesics. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing surgeons with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide analgesic choice and improve patient outcomes. This is a prospective, two-arm randomized implementation study. Eligible participants will be randomly assigned to receive genotype-guided analgesic selection (intervention arm) or usual care (control arm). Both cohorts will undergo pharmacogenetic testing at the time of consenting. The investigators will primarily measure the feasibility of using this test to guide analgesic selection.
Study Details
Timeline
Interventions
Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.
CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone.
Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling