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Suzetrigine in TKA

ConditionsTotal Knee Arthroplasty (TKA)Total Knee Arthroplasty \(TKA\)Total Knee ReplacementTotal Knee Replacement SurgeryTotal Knee ReplacementsTotal Knee Replacement ArthroplastySuzetriginePain ManagementPainNav 1.8JOURNAVXOpioid CessationOpioid Consumption, PostoperativeMultimodal AnalgesiaRandomized Controlled TrialRandomized Controlled StudyRandomized Controlled Trials
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital for Special Surgery, New York

About this trial

Total knee 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 total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing primary TKA with participating surgeons

Age 18 to 80 years old

Planned Discharge to home

Planned use of neuraxial anesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Other intervention

    This will be a placebo drug.

  • 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.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Placebo armPlacebo comparator 1 intervention
Group B: SuzetrigineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative opioid consumption within the first 48 hours after TKA starting from post-anesthesia care unit entry (t=0), in oral morphine equivalents (OME)

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

Secondary outcomes

1

NRS (current at rest, with ambulation, worst & least in last 24 hours) Post-Operative Day (POD) 1-14

Time frame
From admission to the Post Anesthesia Care Unit (PACU) through 14 days postoperatively (Post-Op Day 14)
2

Numeric Rating Scale - post-anesthesia care unit: average, least, worst

Numeric Rating Scale in Post-Anesthesia Care Unit (PACU) ranging from average to least to worst. Post operative pain using Numeric Rating Scale(current at rest, with ambulation, worst \& least in last 24 hours). The Numeric Rating Scale is a simple, widely used tool for measuring pain intensity. It consists of a 0-10 point scale. This will be measured after surgery in the PACU.

Time frame
From arrival in PACU until discharge criteria are met (expected duration up to 2 hours postoperatively).
3

Numeric Rating Scale @Post-Operative Day14, @week 6, @week 12 - average pain, worst & least: last 7 days; current

Numeric Rating Scale measured at 14 days following surgery, then at 6 weeks following surgery and then 12 weeks following surgery. Measurements will range from average pain to worst pain to least amount of pain over the last 7 days and current pain.

Time frame
From 14 days following surgery, 6 weeks from surgery and 12 weeks from surgery.
4

Cumulative Opioid consumption (Oral morphine equivalents = OME): post-anesthesia care unit, 0-24hours, 0 to 168 hours (7 days postoperatively) 0-Post-Operative Day14

Cumulative Opioid consumption (Oral morphine equivalents = OME): Post anesthesia care unit (PACU) at 0 and 24hours, 168 hours, and 14 days (i.e. 7 days postoperatively). The primary outcome is cumulative 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, 0-24hrs, 0-48 hrs and 0-168hrs following surgery.

Time frame
from first time in PACU to 24hours after, then 168hours after, and to 14 days after

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Source ClinicalTrials.gov
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