What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for postoperative pain include opioids, acetaminophen, and NSAIDs. Opioids, such as morphine and fentanyl, can cause side effects like nausea, vomiting, constipation, drowsiness, and respiratory depression. Acetaminophen is generally well-tolerated but can lead to liver toxicity, especially at high doses. NSAIDs, such as ibuprofen and diclofenac, may cause gastrointestinal issues, including ulcers and bleeding, as well as renal impairment and increased cardiovascular risk. These side effects highlight the importance of personalized medicine, such as pharmacogenomics testing, to optimize pain management and minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of postoperative pain, including acetaminophen and codeine, both individually and in combination. Acetaminophen is widely used for its analgesic and antipyretic properties, while codeine, an opioid, is used for its pain-relieving effects. The combination of acetaminophen and codeine has been shown to provide superior pain relief compared to either drug alone. Other FDA-approved treatments for postoperative pain include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and opioids such as morphine and oxycodone. Pharmacogenomics testing aims to optimize these treatments by predicting individual responses based on genetic makeup, potentially improving efficacy and reducing adverse effects.

What other types of research exist?

Promising alternatives to pharmacogenomics testing for postoperative pain management in 2024 include advanced biomarker analysis, machine learning algorithms for predicting drug response, and personalized medicine approaches based on patient history and real-time monitoring.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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.

Select...

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:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient

Pharmacotherapy

Secondary study objectives

Pain

Total opioid consumption in morphine milligram equivalents (MME)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

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.