Suzetrigine in Total Hip Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT07226700
Phase
PHASE3
Status
Recruiting
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Conditions

  • JOURNAVX
  • Multimodal Analgesia
  • Nav 1.8
  • Opioid Cessation
  • Opioid Consumption, Postoperative
  • Pain
  • Pain Management
  • Randomized Controlled Study
  • Randomized Controlled Trial
  • Randomized Controlled Trials
  • Suzetrigine
  • Total Hip Arthroplasty (THA)
  • Total Hip Arthroplasty \(THA\)
  • Total Hip Replacement
  • Total Hip Replacement Arthroplasty
  • Total Hip Replacement Surgery
  • Total Hip Replacements

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Suzetrigine — DRUG
    Suzetrigine is a new novel peripherally acting non-opioid pain medication recently approved by the FDA that exerts its analgesic effects by binding to the peripherally located Nav1.8 Sodium channel receptors present on peripheral nerves.
  • Placebo — OTHER
    This will be a placebo drug.

Study Details

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).

Key Dates

Start date
Nov 3, 2025
Status verified
Jan 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo arm
  • Experimental: Suzetrigine

Primary Outcome Measure

Cumulative opioid consumption within the first 48 hours after THA starting from PACU entry (t=0), in oral morphine equivalents [ Time Frame: From entry into the post-anesthesia care unit (PACU) to 48 hours after THA surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Tina Chen
[email protected]
646-714-6509

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By research site
Hospital for Special Surgery· New York, NY

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