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Pharmacogenetic-guided Choice of Post-surgery Analgesics

Not Applicable
Completed
Conditions
Acute Pain
Post Operative Pain
Registration Number
NCT05548660
Lead Sponsor
University of Pennsylvania
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
112
Inclusion Criteria
  1. Able and willing to provide informed consent
  2. Assigned female at birth and aged 18 years or older at the time of study initiation
  3. Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
  4. Willing to provide a buccal swab for PGx testing and comply with all study-related procedures
Exclusion Criteria
  1. Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
  2. Pregnancy
  3. Breastfeeding
  4. Treating physician does not want subject to participate

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient14 days

The proportion of PGx test results and pharmacist consult notes returned prior to surgery

Fidelity to genotype-guided pharmacotherapy recommendations14 days

The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.

Secondary Outcome Measures
NameTimeMethod
Total opioid consumption in morphine milligram equivalents (MME)14 days

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

Acute pain - Self-reported numeric pain score14 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

Trial Locations

Locations (1)

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States

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