Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Pharmacy will be responsible for randomizing study participants to either the treatment arm or placebo (non-treatment) arm. Both treatment and placebo medications will be made to look identical so that only the pharmacy will know which arm the participant was assigned to.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Suzetrigine 		Participants will receive 100 mg loading dose (2 pills) of Suzetrigine medication pre-operatively, then 50 mg dose (1 pill) of Suzetrigine every 12 hours for total of 5 days.
  • Drug: Suzetrigine
    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.
Placebo Comparator
Placebo 		Participants will receive 2 pills that are made to look like the Suzetrigine pill to take per-operatively, then 1 pill every 12 hours for a total of 5 days.
  • Drug: Placebo
    Matching placebo

Recruiting Locations

Mount Sinai West
New York, New York 10019
Contact:
Michael Lazar, MD
212-523-2500
michael.lazar@mountsinai.org

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Michael Lazar, MD
212-523-2500
michael.lazar@mountsinai.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.