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NCT Number: NCT07548385

Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control.

1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

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Key information

Conditions

Total Knee Replacement Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Adults 18-85 years old
  • Scheduled to undergo total knee replacement surgery
  • All genders

Exclusion criteria

Any individual who meets any of the following criteria will be excluded from participation in this study:

  • American Society of Anesthesiology Physical Classification (ASA) Class V
  • Urgent or emergent surgery
  • Contraindications to administration of Suzetrigine:
  • Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin)
  • Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)
  • Patients with moderate to severe hepatic impairment
  • History of substance use disorder or chronic opioid use or alcohol abuse
  • Reoperation
  • Patient refusal or inability to consent
  • Pregnancy

Treatment and study plan

Suzetrigine

Drug

Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.

Placebo

Drug

Matching placebo

Primary outcomes

  1. Opioid Consumption

    Time frame: 5 days

    Total amount of opioid consumption required post-operatively.

Secondary outcomes

  1. Visual analog pain scale

    Time frame: 5 days

    Participants perceived post-operative pain measured daily using the visual analog scale for pain. Total score is 0 to 10, higher score indicates more pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Himani Bhatt, DO

CONTACT

[email protected]

212-523-2500

Michael Lazar, MD

CONTACT

[email protected]

212-523-2500

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: STRIDE-PAIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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