Pharmacogenetic-Guided Pain Management for Postoperative Pain

(PRECISE Trial)

Overseen By Sony Tuteja, PharmD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Opioids

Disqualifiers: Pregnancy, Breastfeeding, Chronic opioid use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 14 days

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if using genetic information can help doctors choose better pain medications for surgical patients. The goal is to see if this approach can improve pain management by reducing side effects and making sure the medication works well.

Are You a Good Fit for This Trial?

This trial is for individuals assigned female at birth, aged 18 or older, who are about to undergo major gynecologic surgery such as a hysterectomy. Participants must be willing to provide a cheek swab for genetic testing and follow study procedures. Pregnant or breastfeeding individuals, those on long-term opioid therapy, or if their physician advises against participation are excluded.

Inclusion Criteria

I am willing to give a cheek swab for genetic testing and follow all study rules.

I was assigned female at birth and am 18 or older.

Able and willing to provide informed consent

Exclusion Criteria

Pregnancy

Breastfeeding

I have been on prescribed opioids for 3 months or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacogenetic Testing

Participants undergo pharmacogenetic testing at the time of consenting

1 day

1 visit (in-person)

Treatment

Participants receive either genotype-guided analgesic selection or usual care

14 days

4 visits (in-person) on POD 0, 3, 7, 14

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines
• Pharmacist note with genotype-guided analgesic recommendations
• Pharmacogenetic testing

Trial Overview The study tests whether using pharmacogenetic testing (how genes affect drug response) can guide the choice of painkillers after surgery. It's a two-arm study where one group gets genotype-guided analgesic selection and the other receives usual care; both groups will have genetic testing done.

How Is the Trial Designed?

Group I: Usual care Experimental Treatment 2 Interventions

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)

Group II: PGx-guided Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+