Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score (NRS)
研究概览
简要总结
The purpose of this research is to see if a person having an outpatient total knee replacement will have a difference in their pain and the amount of pain medication (opioids) used after discharge if they are given suzetrigine (a non-opioid pain medicine, also known as Journavx®) in addition to the standard pain medicines usually prescribed. Participants will complete a daily pain and medication diary and survey for up to 14 days post-operatively and on day 30.
详细描述
The investigators will be conducting a prospective, randomized, matched cohort study. This is an open-label study. 100 participants undergoing outpatient total knee arthroplasty (TKA) at Endeavor Health with orthopaedic surgeon Dr. Bashyal will be enrolled.
Participants 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, participants 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 participants and explain the study in more detail over the phone and answer any questions. Eligible participants who are still interested in participating will be sent an electronic consent using a dedicated RedCap database that will also be used for participant data collection. Eligible participants will be given time to review the consent and then asked to complete the consent form online should they wish to participate.
Enrolled participants will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician.
Participants 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
排除标准
- •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
研究组 & 干预措施
Suzetrigine and standard care pain medicines
In addition to the standard care pain medicines prescribed for an outpatient total knee arthroplasty, this group will receive a 100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days.
干预措施: Opioid standard care pain medicine (Drug)
Standard care pain medicines
Standard care pain medicines prescribed for an outpatient total knee arthroplasty typically include an opioid such as hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol (Ultram) for as needed post-operative pain relief. The exact opioid and dose prescribed will be up to the discretion of the surgeon and based on what is most appropriate for an individual patient.
干预措施: Opioid standard care pain medicine (Drug)
Suzetrigine and standard care pain medicines
In addition to the standard care pain medicines prescribed for an outpatient total knee arthroplasty, this group will receive a 100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Pain score (NRS)
时间窗: Day 0-14 post-operatively and day 30
Post-operative pain score measured using the Numeric Rating Scale (NRS) system
Pain score (Numeric Rating Scale - NRS)
时间窗: Day 0-14 post-operatively and day 30
The Numeric Rating Scale (NRS) system is used to measure pain. It is a simple 11-point scale from 0 to 10 for quantifying subjective pain intensity. O means "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain" where 10 is the worst pain imaginable.
次要结局
- Cumulative opioid consumption (MME)(Day 0-14 post-operatively and day 30)
研究者
Ravi Bashyal
Orthopaedic Surgeon
Endeavor Health