Pain Management for Nail Diseases

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Overseen ByBrian W Morrison, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Miami
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 aims to determine which pain relief method works best after nail surgery. Participants will receive one of three treatments: suzetrigine (a new potential drug), a combination of oxycodone and acetaminophen, or alternating doses of acetaminophen and ibuprofen. The trial seeks individuals undergoing a nail procedure at Dr. Brian Morrison's clinic who can understand English or Spanish. Those needing pain management options after nail surgery might find this trial suitable. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to benefit from established pain relief methods.

What is the safety track record for these treatments?

A previous study found suzetrigine to be safe and effective for managing post-surgical pain. The FDA has approved it for this use, indicating it has undergone testing and is generally safe. Reports show that over a million prescriptions have been filled, suggesting it is well-tolerated by many patients.

Oxycodone and acetaminophen are common pain relievers. Oxycodone, an opioid, can cause side effects like drowsiness or dizziness but is often used for post-surgical pain. Acetaminophen is also widely used and gentle on the stomach.

Alternating between acetaminophen and ibuprofen is another common pain relief method. Both are available over the counter and are generally well-tolerated. Acetaminophen is easy on the stomach, while ibuprofen reduces swelling due to its anti-inflammatory properties.

Overall, each treatment is widely used and considered safe for most people. Patients should always consult their doctor if they have concerns or health conditions that might affect their treatment.12345

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it offers a new way to manage post-operative pain specifically for nail diseases. Unlike traditional options like acetaminophen/ibuprofen or oxycodone combined with acetaminophen, suzetrigine may work through a novel mechanism that researchers are eager to explore. This investigational treatment could provide effective pain relief with potentially fewer side effects, making it an exciting option for both patients and healthcare providers.

What evidence suggests that this trial's treatments could be effective for post-operative pain management in nail diseases?

This trial will compare different pain management strategies for nail diseases. Studies have shown that suzetrigine, administered to participants in the Suzetrigine Group, effectively manages post-surgery pain. It has enabled 76.1% of patients to recover without needing additional pain relief, avoiding opioids. Suzetrigine acts quickly and provides pain relief comparable to common opioid treatments like hydrocodone/acetaminophen. Participants in the Oxycodone + Acetaminophen Combination Group will receive this well-known option, which effectively relieves moderate to severe pain. Meanwhile, the Alternating Acetaminophen/Ibuprofen Group will receive a non-opioid choice that has managed pain well, offering fewer side effects. Each of these treatments has proven reliable for managing pain, especially after surgery.678910

Who Is on the Research Team?

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Brian Morrison, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for people who have had nail procedures and need pain control afterward. Participants should be able to safely take common pain medications like acetaminophen, ibuprofen, or oxycodone. Those with allergies to these drugs or other health issues that make these medicines unsafe cannot join.

Inclusion Criteria

I am 18 or older, can consent in English or Spanish, and am having a nail procedure at Dr. Morrison's clinic.

Exclusion Criteria

Patients who are pregnant or incarcerated
I am under 18 or unable to give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either suzetrigine, oxycodone+acetaminophen, or alternating acetaminophen/ibuprofen for 5 days for post-operative pain management following nail unit procedures

5 days

Follow-up

Participants are monitored for changes in post-operative pain intensity using the Numeric Rating Scale at 24, 48, and 72 hours post nail procedure

3 days

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen/Ibuprofen
  • Oxycodone + Acetaminophen
  • Suzetrigine

Trial Overview

The study compares three ways to manage pain after nail surgery: a new drug called suzetrigine, the combination of oxycodone and acetaminophen, and alternating doses of acetaminophen and ibuprofen. Patients are randomly assigned to one of these treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Suzetrigine GroupExperimental Treatment1 Intervention
Group II: Oxycodone + Acetaminophen Combination GroupActive Control1 Intervention
Group III: Alternating Acetaminophen/Ibuprofen GroupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Journavx helped most patients avoid opioids after surgery ...

Vertex's Journavx (suzetrigine) allowed 76.1% of patients to recover from laparoscopic or arthroscopic surgery without a single rescue ...

Suzetrigine Versus Usual-care Opioids for Postop Pain in ...

The goal of this clinical trial is to learn if a Suzetrigine-based multimodal pain regimen can reduce the volume of opioid consumption while maintaining ...

Effect of Suzetrigine on Pain Medication Use after Free ...

Conclusion: In free flap patients, perioperative suzetrigine reduced post-operative opioid and non-opioid pain medication usage, as well as the need for ...

Suzetrigine mechanism, efficacy, and clinical implications

While Suzetrigine showed a statistically significant and clinically relevant reduction in pain during Phase III trials, its use on a long-term basis for chronic ...

Suzetrigine in Post Operative Pain - Clinical Trials Registry

In these studies, suzetrigine demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen, with a faster onset of meaningful pain ...

Articles | American Journal of Clinical Dermatology

Exploring Suzetrigine's Role in Dermatologic Surgery: A Novel Nonopioid Analgesic for Postoperative Pain Management

Small Fiber Neuropathy | Continuum

Suzetrigine has US Food and Drug Administration (FDA) approval for acute pain syndromes, demonstrating efficacy in postoperative pain management ...

Lidocaine and Pain Management in the Emergency ...

In the present review, the analgesic effects of lidocaine in acute or chronic painful conditions in the emergency department are discussed.

FDA approves Vertex's Journavx for acute pain

At the end of January 2025, the FDA approved Vertex Pharmaceuticals' Journavx (suzetrigine) as a first-in-class non-opioid analgesic for the ...

Clinical Responses to Cocaine-Positive Urine Drug ...

Urine drug screening (UDS) is commonly incorporated into the monitoring of patients receiving chronic opioid therapy for noncancer pain.