Suzetrigine for pain relief after knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 trial, adults undergoing primary total knee replacement are randomized to receive either suzetrigine or placebo for 14 days, with a loading dose given before surgery. The study aims to see if suzetrigine lowers cumulative 48-hour opioid consumption, supporting opioid-sparing recovery protocols. Eligible participants are adults 18–80 with ASA 1–3 undergoing unilateral TKA and planned discharge home, using neuraxial anesthesia. Exclusion criteria include high cardiovascular risk, chronic opioid use, chronic pain disorders, certain implants, and drug misuse. The trial is conducted at Hospital for Special Surgery, with the Hospital for Special Surgery as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients undergoing primary TKA with participating surgeons
* Age 18 to 80 years old
* Planned Discharge to home
* Planned use of neuraxial anesthesia
* American Society of Anesthesiologist (ASA) Physical Status 1 - 3
* Patients undergoing primary unilateral TKA with participating surgeons

Exclusion Criteria:

* ASA greater than 3
* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)
* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)
* History of QT prolongation
* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device
* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse
* Inability to comply with any component of the study protocol
* Younger than 18 or greater than 80 years old at the time of enrollment
* Patient already on Suzetrigine
* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease/Child Pugh B or C, use of strong CYP3 inhibitors or inducers)
* Contraindications to neuraxial anesthesia or any other part of the study protocol
* Participation in another investigational drug or device study
* Pregnancy
* Prior osteotomy of the operative knee
* Baseline knee flexion \<60°
* History of infection or septic arthritis of the operative knee

Where it's running

• Hospital for Special Surgery
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Meghan Kirskey, MD — Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery
• Study coordinator: Curtis Weh, B.S.
• Email: wehc@hss.edu
• Phone: 917-260-3937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Robotic Mako cementless versus cemented total knee replacement

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• Tramadol vs Morphine for Postoperative Pain After Laparoscopic Abdominal Surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.