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NCT Number: NCT05548660

Pharmacogenetic-guided Choice of Post-surgery Analgesics

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenetic testing

Other

Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.

Pharmacist note with genotype-guided analgesic recommendations

Other

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.

Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines

Other

Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling

Primary outcomes

  1. Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient

    Time frame: 0-30 days

    Number of Participants with PGx Test Results and Pharmacist Consult Notes Returned Per Protocol. Before surgery for the PGx-guided arm, and after surgery for the Usual care arm.

  2. Fidelity to Genotype-guided Pharmacotherapy Recommendations

    Time frame: 14 days

    Number of Participants Prescribed Opioids or NSAIDS According to Genotyping

Secondary outcomes

  1. Acute Pain - Self-reported Numeric Pain Score

    Time frame: 14 days

    Mean patient self-reported numeric pain scores (scale: 0-10, 0 = no pain; 10= worst pain imaginable) assessed on POD 0, 3, 7, 14 in the PGx-guided group vs. the control group

  2. Total Opioid Consumption in Morphine Milligram Equivalents (MME)

    Time frame: 14 days

    Difference in total MME consumption in variant carriers in PGx-guided group vs. control group

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PRECISE

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Sep 21, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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