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临床试验/NCT01718262
NCT01718262已完成不适用

Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion

Defense and Veterans Center for Integrative Pain Management1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Plasma Ropivicaine Levels

研究概览

简要总结

The purpose of the study is to measure the blood levels of the medicine called ropivacaine (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not the subject of this study, but the investigators are studying how much of the drug can be found in the patient's blood, known as the blood level, of this medicine. Too much ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve catheter is removed, local anesthetic toxicity is no longer a potential problem. However, there is little data on what ropivacaine blood levels are after having the catheter in for a long period of time(up to one month).

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
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
  • Written informed consent must be obtained from each patient prior to entering the study
  • Patients must be scheduled to receive a continuous peripheral nerve catheter

排除标准

  • Refusal to have serial blood drawn
  • Contraindication for a continuous peripheral nerve catheter (allergy to local anesthetic, infection at site of injection, elevated coagulation times (international normalized ratio (INR)>1.5, partial thromboplastin time (PTT)>38; these values are drawn as part of routine standard of care and those values will be checked prior to initial catheter insertion), therapeutic dosing of anticoagulation medication, moderate to severe head injury and moderate to severe traumatic brain injury
  • Patients with a hematocrit <
  • Complete Blood Counts (CBCs) are drawn as part of routine standard of care and will be followed by the Acute Pain Service. Although the CBCs and ropivacaine blood draws will not always coincide, we will always check the last hematocrit obtained prior to our blood draw
  • Severe liver or renal disease (values greater than two times normal range)

结局指标

主要结局

Plasma Ropivicaine Levels

时间窗: up to 10 days

Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter.

次要结局

未报告次要终点

研究者

发起方
Defense and Veterans Center for Integrative Pain Management
申办方类型
Other
责任方
Sponsor

研究点 (1)

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