NCT02374320终止2 期
Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
Jose Soberon, MD1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Radial and Ulnar Arterial Diameter
研究概览
简要总结
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •American Society of Anesthesiologists (ASA) status I-IV
排除标准
- •True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
- •Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
- •Pregnancy
- •Severe hepatic impairment
- •Evidence of infection at or near the proposed needle insertion site
- •Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
研究组 & 干预措施
Exparel
Experimental
20 mL liposomal bupivacaine injected once
干预措施: liposomal bupivacaine (Drug)
结局指标
主要结局
Radial and Ulnar Arterial Diameter
时间窗: 1 hour
Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.
次要结局
- Pain Measured by Numerical Rating Scale(1 month)
研究者
Jose Soberon, MD
Anesthesiologist
Ochsner Health System
研究点 (1)
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