Pharmacogenetic-guided Choice of Post-surgery Analgesics

Not Applicable

Completed

• Conditions: Acute Pain; Post Operative Pain
• Interventions: Other: Pharmacogenetic testing; Other: Pharmacist note with genotype-guided analgesic recommendations; Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines

• 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

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Study Start: 2022-10-13
• Primary Completion: 2023-10-20
• Study Completion: 2025-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11

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

Arm && Interventions

Group	Intervention	Description
PGx-guided	Pharmacist note with genotype-guided analgesic recommendations	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.
Usual care	Pharmacogenetic testing	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)
PGx-guided	Pharmacogenetic testing	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.
PGx-guided	Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines	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.
Usual care	Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines	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)

Primary Outcome Measures

Name	Time	Method
Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient	14 days	The proportion of PGx test results and pharmacist consult notes returned prior to surgery
Fidelity to genotype-guided pharmacotherapy recommendations	14 days	The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.

Secondary Outcome Measures

Name	Time	Method
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 score	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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States