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

ConditionsTotal Knee Replacement Surgery Post-operative Pain

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-85

SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18-85 years old

Scheduled to undergo total knee replacement surgery

All genders

Disqualifiers

American Society of Anesthesiology Physical Classification (ASA) Class V

Urgent or emergent surgery

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

235 Participants

are divided into 2 treatment groups

Group A: SuzetrigineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial 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.

Time frame

5 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov

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