Pharmacogenetic-guided Choice of Post-surgery Analgesics

Acute Pain Clinical Trial

— PRECISE  

Official title:

Pharmacogenetic-guided Choice of Post-surgery Analgesics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05548660
• Other study ID #: 851447
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient	The proportion of PGx test results and pharmacist consult notes returned prior to surgery	14 days
Primary	Fidelity to genotype-guided pharmacotherapy recommendations	The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.	14 days
Secondary	Acute pain - Self-reported numeric pain score	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	14 days
Secondary	Total opioid consumption in morphine milligram equivalents (MME)	Difference in total MME consumption in variant carriers in PGx-guided group vs. control group	14 days