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临床试验/NCT02207972
NCT02207972已完成不适用

Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle With Positive CSF Flow, Thereby Facilitating Correct Placement of the Catheter Compared to Catheter Placement Using Palpation of Anatomical Landmarks?

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年5月最近更新:
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
46
试验地点
1
主要终点
Number of Participants With Accurate Epidural Placement

研究概览

简要总结

The investigators believe that ultrasound guided CSE technique will accurately place the epidural needle in the midline position compared to epidural needle placement via palpation of anatomical landmarks. This will result in positive CSF in the spinal needle, correct placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.

详细描述

Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140 surgical patients, a failure rate of 27% for lumbar epidural was described. However, the definition of a failed epidural is broad. Different definitions include insufficient analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia failures may result from technical difficulties, insufficiencies or overdosing of local anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter through an intervertebral foramen or into the anterior epidural space. In an imaging study of failed epidurals, incorrect catheter placement accounted for half of the failures, while the remaining patients experienced suboptimal analgesia through a correctly positioned catheter.

The incidence of overall failure was lower in patients receiving combined spinal-epidural (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased failure rates for labor analgesia and comparable or decreased failure rates for surgical anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed that positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space and also confirms the epidural needle to be in the midline position. Placement of the epidural needle in the midline position will minimize the incorrect placement of the catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.

However, the practice of CSE and epidural catheter placement relies on the palpation of anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter placement will result in a "failed" or suboptimal epidural analgesia.

Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.

研究设计

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

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparious
  • Term (>37 weeks gestation)
  • Vertex presentation
  • Singleton gestation
  • Ability to provide informed consent
  • Request for analgesia for labor pain
  • Maternal age 18 years or greater

排除标准

  • Multiparous
  • Preterm (< 37 weeks gestation)
  • Presentation other than vertex (breech, transverse)
  • Active drug/alcohol dependence
  • Previous spinal surgeries
  • Known spinal deformities

研究组 & 干预措施

Use of Ultrasound

Active Comparator

Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml

干预措施: Use of Ultrasound (Device)

No ultrasound used

Active Comparator

Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml

干预措施: No ultrasound used (Procedure)

结局指标

主要结局

Number of Participants With Accurate Epidural Placement

时间窗: 2 hours

Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position

次要结局

  • Number of Participants With Successful First Attempt(Immediate)
  • Number of Participants Without Angle Adjustments in Space Success(immediate)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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