Suzetrigine in Total Hip Arthroplasty

NCT07226700 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2025-1169
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption within the first 48 hours after THA starting from PACU entry (t=0), in oral morphine equivalents

  The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU). This measure will be taken from EPIC via the MAR and documented in the study "MUD"; post-discharge, patient to report date/time of opioid use # of pills, dose in diary and documented in study "MUD". Measurements will be taken in PACU and 0-48 hrs following surgery.

  From entry into the post-anesthesia care unit (PACU) to 48 hours after THA surgery

Secondary Outcomes (13)

• Post operative pain using Numeric Rating Scale (current at rest, with ambulation, worst & least in last 24 hours) - POD1-7

  From Post Anesthesia Care Unit to post op date 7

• Numeric Rating Scale - PACU: average, least, worst

  From arrival in PACU until discharge criteria are met (expected duration up to 4 hours postoperatively).

• Numeric Rating Scale @POD14, @week 6, @week 12 - average pain, worst & least: last 7 days; current

  From 14 days following surgery, 6 weeks from surgery and 12 weeks from surgery.

• Cumulative Opioid consumption (Oral morphine equivalents = OME): PACU, 0-24hours, 0 to 168 hours (7 days postoperatively)

  from first time in PACU to 24hours after and then 168hours after

• Opioid-free patients through POD2 (0-48hrs), POD7 (0-168hrs), POD14 (0-day 14)

  From start of trial to post operative day 2, 7 and 14

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

Other: Placebo

Suzetrigine

EXPERIMENTAL

Drug: Suzetrigine

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.

Suzetrigine

Placebo OTHER

This will be a placebo drug.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tina Chen

CONTACT

6467146509; chentina@HSS.EDU

William Chan

CONTACT

9172604788; chanw@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)