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临床试验/NCT03100968
NCT03100968已完成不适用

Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Time for Epidural Placement

研究概览

简要总结

This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

详细描述

The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.

In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •patient request for a labor epidural

排除标准

  • •patient refusal of a labor epidural
  • •coagulopathy
  • •platelets<80,000
  • •prior spine procedure or instrumentation
  • •a diagnosis of scoliosis
  • •an intracranial or spinal mass

研究组 & 干预措施

Palpation Group

Active Comparator

The palpation group will have an epidural placed after manual palpation of the spine.

干预措施: Palpation (Procedure)

Ultrasound Group

Active Comparator

The ultrasound group will have an epidural placed after identifying midline with the ultrasound.

干预措施: Ultrasound (Device)

结局指标

主要结局

Time for Epidural Placement

时间窗: Baseline up to 1 hour

Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.

Number of Needle Passes

时间窗: Baseline up to 1 hour

Total Time

时间窗: Baseline up to 1 hour

次要结局

  • Time to Identify Midline(Baseline up to 1 hour)
  • Epidural Failure Rate(Baseline up to 1 hour)
  • Number of Top-offs Required(Baseline up to 1 hour)

研究者

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

Mark Powell

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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