Search > Total Knee Arthroplasty
235 Participants NeededMy employer runs this trial

Suzetrigine for Postoperative Pain

(STRIDE-PAIN Trial)

ML
HB
Overseen ByHimani Bhatt, DO
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: CYP3A inhibitors, CYP3A inducers
Disqualifiers: ASA Class V, Hepatic impairment, Substance use, others
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

ML

Michael Lazar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 85 years old.
My gender does not affect my eligibility.
I am scheduled to have total knee replacement surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine or placebo pre-operatively and continue with doses every 12 hours for 5 days

5 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SuzetrigineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

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