Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Total Time Required for Epidural Catheter Placement
研究概览
简要总结
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Current (pregnant) BMI ≥ 40
- •ASA score of 3 or less
- •Full term pregnancy (37 weeks gestational age or greater)
排除标准
- •Known scoliosis
- •Known contraindications to neuraxial blockade
- •Intrauterine fetal demise or non-viable fetus.
研究组 & 干预措施
Ultrasound Group
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
干预措施: Ultrasound (Device)
Palpation Group
The control group that will have their epidural placed in the usual fashion based on palpation
干预措施: Palpation (Other)
结局指标
主要结局
Total Time Required for Epidural Catheter Placement
时间窗: Assessed immediately during epidural catheter placement
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
次要结局
- Epidural Procedure Time(Assessed immediately during epidural catheter placement)
- Number of Attempts at Epidural Catheter Placement(Assessed immediately during epidural catheter placement)
- Patient Anxiety Level(Assessed immediately following epidural catheter placement)
- Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt(Assessed immediately during epidural catheter placement)
- Complications(Assessed immediately during epidural catheter placement and within 24 hours after delivery)
- Epidural Failure Rate(Assessed within 24 hours after delivery)
- Epidural Catheter Placement Satisfaction Level(Assessed immediately following epidural catheter placement)
- Palpation or Ultrasound Time(Assessed immediately prior to epidural catheter placement)
- Overall Anesthesia Experience Satisfaction(Measured within 24 hours of delivery)
研究者
Thomas J. Vernon
OB Anesthesia Fellow
University of Pittsburgh