NCT02052180Unknown不适用
Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Pain
研究概览
简要总结
The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Age > 18 years
- •ASA physical status 1-3
- •Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
- •Physically and mentally able to participate in the study and complete all study assessments
- •Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.
排除标准
- •History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- •Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
- •Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
- •Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
- •Confirmed pregnancy at time of enrollment
- •Patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf
研究组 & 干预措施
Exparel
Experimental
EXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures.
干预措施: Exparel (Drug)
Control
Active Comparator
15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
干预措施: Marcaine (Control) (Drug)
结局指标
主要结局
Changes in Pain
时间窗: Pre-op, Post-op days: 1,2,3,4, and 14
Pain measured by Numeric Rating Scale (NRS)
次要结局
未报告次要终点
研究者
研究点 (1)
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