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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07548385
Phase
PHASE3
Status
Recruiting
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Conditions

  • Post-operative Pain
  • Total Knee Replacement Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — 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 — DRUG
    Matching placebo

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Feb 23, 2027
Completion
Feb 23, 2027

Study Design

Enrollment
235 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Opioid Consumption [ Time Frame: 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019
Michael Lazar, MD
[email protected]
212-523-2500
Himani Bhatt, DO
[email protected]
212-523-2500
Michael Lazar (PRINCIPAL_INVESTIGATOR)

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