N/A N=112 Randomized Other

Pharmacogenetic-guided Choice of Post-surgery Analgesics

Acute Pain · Post Operative Pain

Bottom Line

View on ClinicalTrials.gov: NCT05548660 ↗

Enrolled (actual)

112

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient — 35; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pharmacogenetic testing (Other); Pharmacist note with genotype-guided analgesic recommendations (Other); Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient	35; 0	—
PRIMARY Fidelity to Genotype-guided Pharmacotherapy Recommendations	32; 31; 23; 24	—
SECONDARY Acute Pain - Self-reported Numeric Pain Score	4.9; 4.6; 5.1; 4.9; 3.7; 3.8	—
SECONDARY Total Opioid Consumption in Morphine Milligram Equivalents (MME)	58.8; 67.8; 37.8; 41.9; 32.3; 36.3	—

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.

Eligibility Criteria

Inclusion Criteria

Able and willing to provide informed consent
Assigned female at birth and aged 18 years or older at the time of study initiation
Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
Willing to provide a buccal swab for PGx testing and comply with all study-related procedures

Exclusion Criteria

Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
Pregnancy
Breastfeeding
Treating physician does not want subject to participate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05548660). 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.