NCT07723352Enrolling By Invitation不适用
A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-80 years.
- •Undergoing thumb basal joint arthroplasty (BJA)
- •Able to provide informed consent.
- •Willing to comply with the study procedures.
排除标准
- •History of substance abuse or chronic opioid use.
- •Known allergies to acetaminophen, oxycodone, or suzetrigine.
- •Severe renal or hepatic dysfunction
- •Estimated glomerular filtration rate less than 15 ml/min/1.73m^2
- •History of kidney transplant
- •Child-Pugh Class C
- •History of liver failure
- •Active hepatitis that can adversely influence hepatic function
- •Has had prior surgery on the study hand within the last 6 months
- •Is currently pregnant, planning to be pregnant, or breastfeeding
- •Use of strong or moderate CYP3A inhibitors or inducers, or medications known to interact with suzetrigine
- •Currently using a prescription pain medication other study medications
结局指标
主要结局
Postoperative pain
时间窗: 5 days
Participants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals
次要结局
未报告次要终点
研究者
tnicholson
Director of Clinical Trials
Rothman Institute Orthopaedics
研究点 (1)
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