Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery

We will be conducting a prospective, randomized, matched cohort study. This is an open-label study. We plan to enroll 100 patients undergoing outpatient total knee arthroplasty (TKA) at Endeavor Health with orthopaedic surgeon Dr. Bashyal.

Subjects will be introduced to the study during their pre-operative surgical visit and/or will receive a surgeon-signed information letter about the study in their pre-operative TKA take-home information packet. With approval from the surgeon, subjects may also (or instead) be sent a signed recruitment letter via the Endeavor Health messaging system by the research team.

Research staff will call eligible patients and explain the study in more detail over the phone and answer any questions the patient may have. Patients who are still interested in participating will be sent an electronic consent using a dedicated RedCap database that will also be used for patient data collection. Patients will be given time to review the consent and then asked to complete the consent form online should they wish to participate.

Enrolled patients will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician.

Patients will be notified of their treatment allocation prior to surgery and will be instructed to collect their filled suzetrigine and/or opioid prescription from Skokie Hospital outpatient pharmacy.

Patients will be provided with a pain medication diary to help track their pain score and medications throughout the day. They will then enter their diary responses into REDCap pain and medication surveys sent via email. Patients who miss surveys will be called by the research team and the information will be collected at that time.

Patient involvement will cease at day 30 post-operatively and any further information (for data up until 90 days postoperatively) will be taken from the medical record.

Inclusion criteria

• outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal

Exclusion criteria

• Allergy to suzetrigine or any of its ingredients
• Contraindication to suzetrigine (eg moderate to severe hepatic impairment, severe renal impairment)
• Previous or current suzetrigine prescription
• Use of a concomitant medication that is a strong CYP3A inhibitor
• Patients unwilling to discontinue use of grapefruit or food and drink containing grapefruit while taking suzetrigine
• Pregnant or lactating women
• Women taking hormonal contraceptives containing progestins other than levonorgestrel and norethindrone must agree to use barrier contraception (eg condoms) or abstain from intercourse during the study or will be excluded from the study for safety reasons
• Pre-operative peripheral nerve stimulation (PNS) system in place
• Age < 18
• Dementia or other mental issue that would interfere with accurate pain and medication reporting
• Those unable to consent in English