Suzetrigine for pain control after primary total hip replacement
Official title: A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty
Run by Hospital for Special Surgery, New York · NCT07226700 · Data updated 2026-11-12
This will test whether taking Suzetrigine before surgery and for seven days afterward reduces opioid use and improves pain control in adults having a primary total hip replacement.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2028 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07226700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 undergoing primary posterior-approach total hip arthroplasty with planned neuraxial anesthesia, discharge to home, and ASA physical status 1–3 who are not chronic opioid users are ideal candidates.
✕Probably not a fit
Patients who are chronic opioid users, have chronic pain syndromes, implantable cardiac devices, QT prolongation, uncontrolled substance misuse, or who are outside the 18–80 age range are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, placebo-controlled Phase 3 trial enrolling adults undergoing primary posterior-approach total hip arthroplasty at a single center. Participants receive a loading dose before surgery and then Suzetrigine or placebo daily for seven days, with planned neuraxial anesthesia and discharge to home. The primary endpoint is cumulative opioid consumption over the first 48 hours after arrival in the post-anesthesia care unit, reported in oral morphine equivalents. Secondary measures include pain scores and opioid-related side effects to assess recovery and opioid-sparing effects.
Why it matters
Potential benefit: If successful, Suzetrigine could reduce opioid use after hip replacement, speeding recovery and lowering opioid-related side effects and dependence risk.
How similar studies have gone: Other clinical trials of Suzetrigine (VX-548) have shown efficacy in acute postoperative pain and the drug received FDA approval for acute pain, but its specific benefit after hip replacement is being tested here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where it's running
-
Hospital for Special Surgery
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Tina Chen
- Email: chentina@HSS.EDU
- Phone: 6467146509
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.