Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

Phase 3RecruitingNCT07548385

Icahn School of Medicine at Mount Sinai235 enrolled

Overview

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

235

Conditions

Total Knee Replacement Surgery Post-operative Pain

Interventions

Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: * Adults 18-85 years old * Scheduled to undergo total knee replacement surgery * All genders Exclusion Criteria: Any individual who meets any of the following criteria will be excluded from participation in this study: * American Society of Anesthesiology Physical Classification (ASA) Class V * Urgent or emergent surgery * Contraindications to administration of Suzetrigine: * Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin) * Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin) * Patients with moderate to severe hepatic impairment * History of substance use disorder or chronic opioid use or alcohol abuse * Reoperation * Patient refusal or inability to consent * Pregnancy

Outcomes

Primary Outcomes

Opioid Consumption

Total amount of opioid consumption required post-operatively.

Time frame: 5 days

Secondary Outcomes

Visual analog pain scale

Participants perceived post-operative pain measured daily using the visual analog scale for pain. Total score is 0 to 10, higher score indicates more pain.