148 Participants NeededMy employer runs this trial

Suzetrigine for Pain Management in Total Knee Replacement

HG
CW
Overseen ByCurtis Weh, B.S.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hospital for Special Surgery, New York
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 tests a new drug, suzetrigine, to determine its effectiveness in managing pain after knee replacement surgery. The goal is to reduce opioid use, which can cause side effects like nausea and long-term dependency. Participants will receive either suzetrigine or a placebo (a pill with no active medicine) for two weeks, starting just before surgery. This trial suits individuals undergoing their first knee replacement, planning to return home after surgery, and not regularly using opioids. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking treatment.

Is there any evidence suggesting that suzetrigine is likely to be safe for humans?

Studies have shown that suzetrigine is generally well-tolerated by patients undergoing knee replacement surgery. Research indicates that this medication can manage pain without causing side effects often linked to opioids, such as nausea or addiction. Earlier studies found that suzetrigine did not cause major side effects, suggesting it is safe for post-surgery pain relief. While suzetrigine remains under testing, these findings offer promising evidence of its safety in humans.12345

Why do researchers think this study treatment might be promising?

Most treatments for pain management after total knee replacement, like opioids and NSAIDs, focus on reducing inflammation or blocking pain signals. But Suzetrigine works differently, targeting nerve pathways to modulate pain perception at the source. Researchers are excited because this new mechanism of action could offer effective pain relief without the common side effects associated with traditional pain medications. This innovative approach holds promise for providing patients with a safer and potentially more effective option for managing post-surgical pain.

What evidence suggests that suzetrigine might be an effective treatment for pain management in total knee replacement?

Research has shown that suzetrigine, which participants in this trial may receive, might help manage pain after knee replacement surgery. Studies suggest this treatment could reduce the need for opioids, commonly used for pain relief but often causing side effects like nausea and addiction. Suzetrigine targets specific pain pathways, potentially lowering pain and speeding up recovery. In earlier trials, patients using suzetrigine required less opioid medication compared to those taking a placebo, indicating its potential to effectively reduce pain. This suggests suzetrigine could make recovery smoother and less dependent on opioids.678910

Who Is on the Research Team?

MK

Meghan Kirskey, MD

Principal Investigator

Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery

AS

Alexandra Sideris, PhD

Principal Investigator

Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have their first total knee replacement surgery. Participants should be able to follow study instructions and not have conditions or medications that could interfere with the trial, such as certain seizure disorders.

Inclusion Criteria

Planned discharge to home
I am having my first knee replacement surgery with a participating surgeon.
American Society of Anesthesiologist (ASA) Physical Status 1 - 3
See 3 more

Exclusion Criteria

Pregnancy
Inability to comply with any component of the study protocol
Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either suzetrigine or placebo for 2 weeks, with the loading dose administered prior to surgery

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of opioid consumption, pain management, and adverse events

12 weeks

Long-term follow-up

Participants may be monitored for additional outcomes such as opioid refills and knee function up to 2 years after surgery

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares suzetrigine, a new pain medication, against a placebo in people recovering from knee replacement surgery. Patients are randomly assigned to receive either suzetrigine or placebo for 14 days starting before surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SuzetrigineExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Citations

1.

journals.lww.com

journals.lww.com/pain

PAIN

Explore PAIN, featuring peer‑reviewed articles, clinical studies, and the latest medical research.

2.

en.wikipedia.org

en.wikipedia.org/wiki/Pain

Pain

Simple over-the-counter pain medications are useful in 20% to 70% of cases of common acute pain, such as post-tooth extraction pain.

PAIN

1% reduction in intensity was treated as equivalent to approximately a 3% reduction in distribution, be routinely considered in pain management alongside ...

Pain Management Resource Center

Here you'll find the latest pain management information including treatments, ... mind-body techniques, and acupuncture can help relieve chronic pain. ...

5.

medlineplus.gov

medlineplus.gov/pain.html

Pain

Chronic pain lasts for longer than three months. Treatment depends on the cause and type of pain. Treatments may include medicines, such as ...

Study Details | NCT07219888 | Comparison of Suzetrigine ...

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Emerging Nonopioid Analgesic Strategies in Total Joint ...

Meloxicam versus celecoxib for Postoperative Analgesia after total knee arthroplasty: safety, efficacy and cost. J Am Acad Orthop Surg Glob ...

Comparison of Suzetrigine and Oxycodone for Postoperative ...

Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing ...