Trial intelligence / Profile preview

Suzetrigine in Total Knee Arthroplasty

NCT07864896Phase 3

Key facts

Status: Recruiting
Start: Oct 2026
Primary completion: Jan 2029
Countries: 1
Sponsor: Hospital for Special Surgery

Drugs: suzetrigine
Conditions: postoperative pain

Overview

Phase 3, randomised, double-blind trial in postoperative pain comparing Placebo arm with Suzetrigine (2 arms). Primary endpoint: Cumulative opioid consumption at 48 hours. Started Oct 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Placebo arm
Placebo for 2 weeks
Suzetrigine
Suzetrigine for 2 weeks

Who it enrols

Adults aged 18-80 undergoing primary total knee arthroplasty with planned discharge to home and neuraxial anesthesia, excluding those with chronic opioid use, chronic pain syndromes, severe liver disease, or specific cardiac conditions.

Endpoints

Primary

Cumulative opioid consumption48 hours

Secondary

Numeric Rating Scale12 weeks
Opioid-free patients14 days
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement6 weeks
Range of Motion6 weeks
Rate of manipulation under anesthesia12 weeks
Incidence of adverse events14 days

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