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临床试验/NCT02626559
NCT02626559已完成不适用

Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty

University of Utah1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年11月最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Serum Bupivacaine levels

研究概览

简要总结

Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

排除标准

  • Known hepatic dysfunction or renal insufficiency (creatinine > 1.5 mg/dL);
  • allergy to the study medications;
  • pregnancy;
  • incarceration;
  • inability to communicate with the investigators;
  • morbid obesity (body mass index > 40 kg/m2).

结局指标

主要结局

Serum Bupivacaine levels

时间窗: 5 minutes to 24 hours after injection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Buys

Assistant Professor

University of Utah

研究点 (1)

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