Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT07226700

Suzetrigine in Total Hip Arthroplasty

Led by Hospital for Special Surgery, New York · Updated on 2026-01-29

210

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

CONDITIONS

Official Title

Suzetrigine in Total Hip Arthroplasty

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing primary THA (posterior approach) with participating surgeons
  • Age 18 to 80 years old
  • Planned discharge to home
  • Planned use of neuraxial anesthesia
  • American Society of Anesthesiologists (ASA) Physical Status 1 - 3
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

M

Maaz S Khan, MD

CONTACT

W

William Chan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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