Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
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.
- Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery?
- 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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Pharmacy will be responsible for randomizing study participants to either the treatment arm or placebo (non-treatment) arm. Both treatment and placebo medications will be made to look identical so that only the pharmacy will know which arm the participant was assigned to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Adults 18-85 years old
- •Scheduled to undergo total knee replacement surgery
- •All genders
排除标准
- •Any individual who meets any of the following criteria will be excluded from participation in this study:
- •American Society of Anesthesiology Physical Classification (ASA) Class V
- •Urgent or emergent surgery
- •Contraindications to administration of Suzetrigine:
- •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)
- •Patients with moderate to severe hepatic impairment
- •History of substance use disorder or chronic opioid use or alcohol abuse
- •Reoperation
- •Patient refusal or inability to consent
- •Pregnancy
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: 5 days
Total amount of opioid consumption required post-operatively.
次要结局
- Visual analog pain scale(5 days)
研究者
Michael Lazar
Assistant Professor
Icahn School of Medicine at Mount Sinai