Pharmacogenetic-guided Choice of Post-surgery Analgesics

NCT05548660 | Completed Results

• 1 other identifier: 851447
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Post Operative Pain

Outcome Measures

Primary Outcomes (2)

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

  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.

  0-30 days

• Fidelity to Genotype-guided Pharmacotherapy Recommendations

  Number of Participants Prescribed Opioids or NSAIDS According to Genotyping

  14 days

Secondary Outcomes (2)

• Acute Pain - Self-reported Numeric Pain Score

  14 days

• Total Opioid Consumption in Morphine Milligram Equivalents (MME)

  14 days

Study Arms (2)

PGx-guided

EXPERIMENTAL

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.

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

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)

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

Interventions

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.

PGx-guided; Usual care

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.

PGx-guided

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

PGx-guided; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Sony Tuteja, PI
• Organization: University of Pennsylvania

Sony.Tuteja@PennMedicine.upenn.edu

215-573-7834

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine, Division of Translational Medicine and Human Genetics; Assistant Director, Pharmacogenomics Penn Center for Precision Medicine

Model Details: Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: October 13, 2022
• Primary Completion: October 20, 2023
• Study Completion: February 1, 2025
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol, SAP, ICF will be made available 1 year following enrollment of the last participant. IPD will be made available 6 months after publication of study results
• Access Criteria: Contact PI, Sony Tuteja, PharmD, sonyt@pennmedicine.upenn.edu with individual requests.

Locations

US (1)