跳至主要内容
临床试验/NCT01243216
NCT01243216撤回不适用

The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients

University of Missouri-Columbia2 个研究点 分布在 1 个国家开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Number of attempts needed for proper needle placement

研究概览

简要总结

The investigators are interested in determining the utility of ultrasound of the spine for labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The investigators hypothesized that in women with poor spinal landmarks that the use of ultrasound of the spine will improve the process of placing labor epidurals or spinal anesthetics

详细描述

Ultrasound has been in use for peripheral regional anesthesia for several years and is becoming more common. It is currently routinely used here at the University of Missouri. Ultrasound for neuraxial anesthesia, however, is less common and is only being done in a few centers.. There have been several case reports of its use in obstetric anesthesia for patients with prior spinal surgery or spinal deformity. There have been even few prospective randomized studies. While its use may have significant advantages, it is not yet clear what those advantages are and in whom it may be most beneficial. The investigators seek to answer the following questions regarding the use of preprocedure ultrasound for neuraxial analgesia/anesthesia in obstetric patients:

  • Are there benefits to the use of pre procedure ultrasound for neuraxial analgesia/anesthesia?
  • If so, what are the benefits?
  • If measurable, to what extent does the patient benefit?
  • Do all patients benefit or only a specific subgroup?
  • Is there a "cost" to the use of pre procedure ultrasound, i.e. extra time needed to perform the ultrasound exam vs a "savings" with the use of pre procedure ultrasound, i.e., less time to perform the epidural analgesic or spinal anesthetic as a direct result of the use of ultrasound?
  • In particular the investigators hypothesize that in patients whose spinal landmarks are not palpable or are barely palpable, ultrasound will be found to be beneficial as determined by metrics described below (see item #6). In patients whose landmarks are prominent or easily palpable pre procedure ultrasound will not be of significant benefit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in labor
  • Women scheduled for cesarean delivery

排除标准

  • Under age 18
  • Emergency cesarean deliveries
  • Unable to cooperate with ultrasound examination or regional anesthesia
  • Advanced labor
  • Contraindications to regional anesthesia
  • Unable to understand the consent process

结局指标

主要结局

Number of attempts needed for proper needle placement

时间窗: 30 min or less

An attempt is defined as a separate needle puncture. A needle pass is defined as the passage of a needle through a single puncture site

次要结局

  • Patient Satisfaction(30 min)
  • Time(30 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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