Suzetrigine vs Oxycodone for Postoperative Pain

LS
LG
Overseen ByLibbee Galloway, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Louisville
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 if suzetrigine manages pain more effectively than oxycodone after knee replacement surgery due to osteoarthritis. Participants will receive either suzetrigine (a new potential drug) with some oxycodone for backup or just oxycodone. The researchers aim to see if suzetrigine can reduce the need for painkillers after surgery. This trial suits those planning a knee replacement due to osteoarthritis, who have not recently used opioids, and who can read and speak English. As a Phase 4 trial, suzetrigine is already FDA-approved and proven effective, and this research helps understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you have not taken opioids in the 90 days before joining. Other medications are not mentioned, so it's best to ask the trial team for more details.

What is the safety track record for these treatments?

Earlier studies have shown that suzetrigine works well and is safe for managing post-surgical pain. Research indicates it can reduce the need for opioids, which are strong painkillers with addiction risks. One study found that about 90% of patients using suzetrigine recovered without needing opioids. Additionally, the FDA has approved suzetrigine for pain management, confirming its safety. Overall, current evidence supports suzetrigine as a safe choice for individuals recovering from surgery.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for postoperative pain rely on opioids like oxycodone, which work by blocking pain signals in the brain but come with risks of addiction and side effects. Suzetrigine is unique because it potentially offers effective pain relief with a different mechanism of action, possibly reducing the reliance on opioids. Researchers are excited about suzetrigine because it might provide a safer alternative to traditional opioid treatments, with fewer side effects and lower risk of dependency. This could revolutionize how we manage postoperative pain by offering a more sustainable and safer option.

What evidence suggests that suzetrigine might be an effective treatment for postoperative pain?

Research has shown that suzetrigine helps reduce pain after surgery. In studies, it relieved pain more effectively than a placebo for individuals recovering from surgeries like tummy tucks and bunion removals. One study found that nearly 91% of patients managed their pain without needing opioids. In this trial, participants in Group A will receive suzetrigine, with a small supply of Oxycodone as a rescue medication. This suggests that suzetrigine might help people avoid opioid side effects, such as dizziness or addiction. Overall, suzetrigine appears to be a promising pain reliever after surgery.56789

Who Is on the Research Team?

RZ

Rodolfo Zamora, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults aged 21-89 who are having their first knee replacement surgery due to osteoarthritis. Participants must speak and read English, not be pregnant or nursing, have no allergies to suzetrigine, and haven't used opioids in the past 90 days.

Inclusion Criteria

I am between 21 and 89 years old.
I am scheduled for my first knee replacement on one knee due to osteoarthritis.
Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
See 1 more

Exclusion Criteria

Patient is unable to read and speak English
Contraindication or Hypersensitivity to suzetrigine
Pregnant or nursing females
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total knee arthroplasty and receive either suzetrigine or oxycodone for postoperative pain management

2 weeks
Daily tracking of pain medicine usage and VAS pain level

Follow-up

Participants return for follow-up visits to assess pain levels, opioid usage, and functionality

6 weeks
2 visits (in-person) at 2 weeks and 6 weeks postop

What Are the Treatments Tested in This Trial?

Interventions

  • Oxycodone
  • Suzetrigine

Trial Overview

The study compares two oral pain medications—suzetrigine and oxycodone—for managing pain after knee replacement surgery. Patients are randomly assigned to receive one of these drugs after their operation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group A: suzetrigine groupExperimental Treatment1 Intervention
Group II: Group B: Oxycodone groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40117446/

Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of ...

As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy.

Association of Suzetrigine With Postoperative Outcomes ...

A novel non-opioid analgesic, Suzetrigine, may be able to effectively manage postoperative pain without some of the psychological and economic ...

The effectiveness and value of suzetrigine for moderate ...

Suzetrigine demonstrated superior pain relief compared with placebo in both trials; the least squares mean difference (LSMD) in SPID48 between ...

Vertex to Present New Data on JOURNAVX® That ...

The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, ...

Data Support Suzetrigine's Use for Acute Pain Following ...

Phase 4 data show suzetrigine controls post–plastic surgery pain, keeping nearly 91% of patients opioid free with good pain ratings and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.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 ...

Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...

These randomized, double-blind studies assessed the analgesic efficacy of suzetrigine in postoperative pain management following bunionectomy ...

Pain Suzetrigine Data Reveal Reduced Postoperative ...

SALT LAKE CITY—New data show that suzetrigine (Journavx, Vertex) results in opioid-free recovery for 90.9% of patients treated with the ...

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

It's efficacy in reducing postoperative opioid exposure without sacrificing pain control after common ambulatory orthopaedic sports procedures ...