Suzetrigine for Postoperative Pain

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
Must be taking: Suzetrigine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well the medication suzetrigine manages pain after facial plastic surgery. The researchers aim to determine if suzetrigine can control pain, reduce opioid use, and improve recovery. It targets adults undergoing elective facial plastic surgery, where doctors plan to use suzetrigine for pain management. This study may suit those having this type of surgery and willing to try suzetrigine instead of opioids. As a Phase 4 trial, suzetrigine has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, especially if you are using strong CYP3A4 inhibitors like itraconazole or grapefruit juice, as these are not allowed in the trial.

What is the safety track record for suzetrigine?

Research has shown that suzetrigine is a safe option for managing post-surgical pain. The FDA has approved suzetrigine, a non-opioid medication, for treating moderate to severe pain, indicating trust in its safety for patients.

Studies have found that suzetrigine is well-tolerated and provides effective pain relief without the need for opioids, resulting in fewer side effects and a lower risk of addiction. A review of studies found that suzetrigine generally has a good safety record, with most people experiencing only mild or no side effects.

When considering participation in a trial for suzetrigine, current research supports its safety and highlights it as a promising alternative to traditional pain medications.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care, which often relies on opioids for managing postoperative pain, Suzetrigine acts as an alternative pain management option without the dependency risks associated with opioids. Researchers are excited about Suzetrigine because it potentially offers effective pain relief without the side effects and addiction concerns linked to opioid use. This could revolutionize how postoperative pain is managed, making recovery safer and more comfortable for patients.

What is the effectiveness track record for suzetrigine in managing postoperative pain?

Research has shown that suzetrigine, which participants in this trial will receive, effectively manages post-surgical pain. In some studies, suzetrigine reduced pain by about 3 points on a pain scale within 48 hours after surgery, while a placebo reduced it by only 2 points. Other studies indicate that it provides good pain relief with fewer side effects than traditional opioid medications. Specifically, patients using suzetrigine reported significant pain improvement over 48 hours. This suggests that suzetrigine can be a reliable option for managing post-surgical pain, especially for those seeking to avoid opioids.678910

Who Is on the Research Team?

DC

Deanna C. Menapace, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having elective outpatient facial plastic surgery and can follow the study's procedures. They must be willing to use suzetrigine for pain after surgery. It's not open to pregnant or breastfeeding women, those allergic to suzetrigine, people under 18, women on hormonal birth control not counseled about suzetrigine, or anyone taking certain strong medications.

Inclusion Criteria

Able to consent and comply with study procedures
I am an adult planning to have elective facial plastic surgery.
My doctor plans to prescribe suzetrigine after my surgery.

Exclusion Criteria

Pregnant or breastfeeding
Known allergy to suzetrigine
Vulnerable or protected research populations
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive suzetrigine for postoperative pain management instead of opioids

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine
Trial Overview The study is testing if suzetrigine can help manage pain after facial plastic surgery without needing opioids. Participants will receive suzetrigine as part of their usual care after surgery, and researchers will track their pain levels, opioid use, and recovery process.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SuzetrigineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

The effectiveness and value of suzetrigine for moderate ...Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in the ...
Efficacy and Safety of Suzetrigine for Acute Postoperative ...In conclusion, suzetrigine appears to offer a balanced approach to postoperative pain management, providing effective analgesia with a favorable ...
More Data on Suzetrigine, a Novel Nonopioid Pain ...By 48 hours after surgery, suzetrigine led to an average pain reduction of ≈3 points versus ≈2 points with placebo. Suzetrigine provided similar ...
NCT07257133 | A Study Of Opioid Avoidance In Surgery ...This prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult ...
Suzetrigine: Advancing Acute Pain Management Beyond ...In both studies, suzetrigine produced a statistically and clinically significant improvement in pain scores over 48 hours compared to placebo, ...
FDA Approves Novel Non-Opioid Treatment for Moderate ...The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41222511/
Efficacy and Safety of Suzetrigine for Acute Postoperative ...These findings suggest that suzetrigine offers effective and well-tolerated analgesia, supporting its role in opioid-sparing postoperative pain ...
NCT07195669 | RCT: Suzetrigine vs Norco for Post-op PainThis study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.
Suzetrigine for acute postoperative pain: a systematic ...In conclusion, suzetrigine appears to offer effective perioperative analgesia with a favourable safety profile. Although further research is ...
The effectiveness and value of suzetrigine for moderate ...We evaluated the efficacy and safety of suzetrigine in adults with moderate to severe acute pain against 4 treatment modalities.
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