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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic testing (pharmacogenetic testing) can help doctors select the best pain medication for patients after surgery. It will assess whether knowing a patient's genetic makeup can prevent side effects or enhance medication effectiveness. Participants will receive pain medication either based on their genetic test results or through the usual care without these results. Women planning major gynecologic surgery, such as a hysterectomy, and willing to provide a cheek swab for testing may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could personalize pain management for future patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic opioid therapy, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pharmacogenetic testing, which examines how genes affect drug responses, is generally well-received by patients. Studies have found that using this testing to guide pain management can lead to fewer side effects. For instance, one study discovered that pharmacogenetic guidance reduced the need for strong painkillers by 50%. This testing helps doctors choose safer and more effective pain treatments. Another review examined the use of genetic information to guide opioid pain treatment and found it both effective and safe. Overall, existing research indicates that pharmacogenetic testing for pain management is safe and may help reduce negative effects from pain medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharmacogenetic-guided pain management approach because it tailors postoperative pain treatment to an individual's genetic makeup. Unlike standard pain management, which often relies on a one-size-fits-all use of medications like opioids or NSAIDs, this method utilizes a 16-gene panel to guide drug selection based on specific genetic markers, such as CYP2D6 and CYP2C9. This personalized strategy not only aims to optimize pain relief but also minimizes the risk of adverse drug reactions, making it a promising advancement in postoperative care.

What evidence suggests that this trial's treatments could be effective for postoperative pain management?

This trial will compare pharmacogenetic-guided pain management with usual care for postoperative pain. Studies have shown that genetic testing can enhance pain management after surgery. Research indicates that using a patient's genetic information to select appropriate painkillers can improve pain control and reduce side effects. For example, certain genes influence the effectiveness of some pain medications. One study found that using genetic information to guide pain treatment made opioid use safer and more effective. Additionally, patients receiving care based on their genetic information often report better pain relief than those receiving standard care without genetic guidance. ^{1 2 3 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048650/

Pharmacogenetic Approaches in Personalized Medicine for ... This review aims to summarize and update how genotype-guided therapeutics within personalized medicine can enhance postoperative pain management.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521689620300409

Can it change outcomes in postoperative pain management? We first review a number of genotypes that have shown correlations with pain and opioid use and then describe the importance of PGx-guided analgesic protocols ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02605343

Prospective Observational Clinical Study to Evaluate ... The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34013775/

Efficacy and safety of opioid therapy guided by ... Aim: To perform a systematic review to determine the efficacy/safety of PGx-guided opioid therapy for chronic/postoperative pain.

5. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/pdf/10.1111/cts.70154

Effectiveness Trial Comparing Pharmacogenomics (PGx) to ... We performed a randomized type 2 hybrid- effectiveness trial to identify the effects of providing PGx results and recommendations for patients ...

6. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Pharmacogenetic-Testing-Pain-Management.pdf

Pharmacogenetic Testing for Pain Management Testing for genetic variants that are relevant to pharmacokinetics or pharmacodynamics of analgesics may assist in selecting and dosing drugs.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961016308169

Pharmacogenetics-guided analgesics in major abdominal ... Pharmacogenetics guidance resulted in frequent modifications of the analgesic program, resulting in excellent analgesia with a 50% reduction in narcotic ...