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Pharmacogenomics

Pharmacogenetic-Guided Pain Management for Postoperative Pain (PRECISE Trial)

N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

Summary

This trial is looking at whether or not providing surgeons with information about a patient's genes and how they respond to drugs can help improve patient outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on personalized medication choices based on genetics rather than new drugs, side effects would relate to individual responses to standard painkillers used post-surgery which could include nausea, constipation, dizziness, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was assigned female at birth and am 18 or older.
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I am scheduled for major surgery related to female reproductive organs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on prescribed opioids for 3 months or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
Pharmacotherapy
Secondary outcome measures
Pain
Total opioid consumption in morphine milligram equivalents (MME)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual careExperimental Treatment2 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-guidedExperimental Treatment3 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Postoperative pain is commonly managed using acetaminophen, NSAIDs, gabapentinoids, and ketamine. Acetaminophen works centrally to inhibit prostaglandin synthesis, reducing pain and fever. NSAIDs inhibit cyclooxygenase enzymes (COX-1 and COX-2), decreasing inflammation and pain. Gabapentinoids, such as gabapentin and pregabalin, modulate calcium channels to reduce neuronal excitability and pain transmission. Ketamine, an NMDA receptor antagonist, prevents central sensitization and reduces pain perception. Understanding these mechanisms is crucial for tailoring pain management to individual patients, especially when considering pharmacogenomics testing, which can predict drug response based on genetic makeup, potentially improving efficacy and reducing adverse effects.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,885,599 Total Patients Enrolled

Media Library

Pharmacogenetic testing (Pharmacogenomics) Clinical Trial Eligibility Overview. Trial Name: NCT05548660 — N/A
Postoperative Pain Research Study Groups: PGx-guided, Usual care
Postoperative Pain Clinical Trial 2023: Pharmacogenetic testing Highlights & Side Effects. Trial Name: NCT05548660 — N/A
Pharmacogenetic testing (Pharmacogenomics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548660 — N/A
~41 spots leftby Jul 2025