Pharmacogenetic-guided Choice of Post-surgery Analgesics (PRECISE)

University of Pennsylvania

Status: Completed

Conditions: Acute Pain; Post Operative Pain

Treatments: Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines; Other: Pharmacist note with genotype-guided analgesic recommendations; Other: Pharmacogenetic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05548660

851447

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

PGx-guided

Experimental group

Description:

Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.

Treatment:

Other: Pharmacogenetic testing

Other: Pharmacist note with genotype-guided analgesic recommendations

Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines

Usual care

Other group

Description:

Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)

Treatment:

Other: Pharmacogenetic testing

Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines