Suzetrigine in Total Hip Arthroplasty

NCT07226700 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-01-29

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Suzetrigine

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.

OTHER

Placebo

This will be a placebo drug.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2027-11-01
Completion
2028-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226700 on ClinicalTrials.gov