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Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals

Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study

Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.

The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

45

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G1X5
        • Mount Sinai Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不适用

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Women who have delivered under epidural analgesia, either with vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

描述

Inclusion Criteria:

  • Women who have delivered under epidural analgesia
  • Women who have vaginal or caesarean delivery
  • Women with the epidural catheter still in place

Exclusion Criteria:

-Women who experience fetal or maternal complications during delivery

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
因分娩而接受硬膜外麻醉的患者
因分娩而接受硬膜外麻醉的患者可以参加。 研究程序将在分娩后和硬膜外导管移除前进行。
Doppler ultrasonography

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
大体时间:15 min
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
15 min

次要结果测量

结果测量
措施说明
大体时间
Level of epidural catheter insertion: questionnaire
大体时间:5 min
The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
5 min
Epidural regimen: questionnaire
大体时间:5 min
Settings for the epidural pump as charted by the anesthesiologist and the nurse.
5 min
Maximum upper sensory block to ice: questionnaire
大体时间:5 min
Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
5 min
Any anesthetic intervention for patchy or asymmetric block
大体时间:5 min
The anesthetic record will be reviewed for any interventions done.
5 min
Number of manual epidural top ups
大体时间:5 min
The number of top ups given by nurses or physicians manually will be recorded from the chart.
5 min
Number of PCEA (patient controlled epidural analgesia) boluses delivered
大体时间:5 min
Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
5 min
Duration of epidural analgesia
大体时间:5 min
Time of epidural placement to delivery or placement to top up for caesarean delivery.
5 min
Quality of analgesia questionnaire - 1st stage
大体时间:5 min

Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 :

On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated?

5 min
Quality of analgesia questionnaire - 2nd stage
大体时间:5 min

Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10:

On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby?

5 min

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月17日

初级完成 (实际的)

2022年6月6日

研究完成 (实际的)

2022年6月6日

研究注册日期

首次提交

2021年10月25日

首先提交符合 QC 标准的

2021年11月18日

首次发布 (实际的)

2021年11月19日

研究记录更新

最后更新发布 (实际的)

2022年7月29日

上次提交的符合 QC 标准的更新

2022年7月27日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 21-07

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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