What this study is
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.
What's being tested
- Suzetrigine
Intervention · DRUG
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
Intervention · DRUG
Matching placebo
Study details
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Total Knee Replacement Surgery · Post-operative Pain
- Enrolling
- 235 people
- Starts
- 2026-04
- Est. completion
- 2027-02-23
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults 18-85 years old
- Scheduled to undergo total knee replacement surgery
- All genders
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMount Sinai West
New York, New York, United States
- Michael Lazar, MD · Contact212-523-2500michael.lazar@mountsinai.org
- Himani Bhatt, DO · Contact212-523-2500himani.bhatt@mountsinai.org
- Michael Lazar · Principal investigator
Recruiting
Study team
Sponsor
Icahn School of Medicine at Mount Sinai
Study ID STUDY-25-01392
Principal investigator
Michael Lazar, MD
Icahn School of Medicine at Mount Sinai
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.