分娩镇痛时置入柔性硬膜外导管的难度评价:一项观察性、开放标签、随机试验

2021
10/14

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米勒之声
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虽然柔性硬膜外导管降低了感觉异常和血管内置管的风险,但它们可能更难越过Tuohy针的尖端。

本文由“罂粟花”授权转载

分娩镇痛时置入柔性硬膜外导管的难度评价:一项观察性、开放标签、随机试验

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贵州医科大学 麻醉与心脏电生理课题组  

翻译:潘志军  编辑:张中伟  审校:曹莹

背景

虽然柔性硬膜外导管降低了感觉异常和血管内置管的风险,但它们可能更难越过Tuohy针的尖端。当分娩镇痛穿刺时,这可能会增加置管时间、尝试次数和可能的并发症。本研究从两种商业上常用的硬膜外麻醉包中获得不同的硬膜外穿刺针,并测试其置入柔性硬膜外导管的难易程度  。

方法

我们假设,在分娩镇痛穿刺时,多孔钢丝增强聚酰胺尼龙混合硬膜外导管比单孔钢丝增强聚氨酯导管具有更高的首次尝试插入成功率。主要结局指标是两种硬膜外麻醉包未能置入硬膜外导管的比例存在差异,并用χ  2  检验进行检验。在2018年11月至2019年9月的开放标签临床试验中,我们为240名要求硬膜外镇痛的分娩患者收集了240个硬膜外麻醉包(n=120/组)。在本研究中,随机分配的任何一种麻醉包的研究期为两周,即所有患者通过柔性硬膜外导管“A”或柔性硬膜外导管“B”进行分娩镇痛。以此确定所用硬膜外麻醉包的工程特性。

结果

柔性硬膜外导管“A”,即单端孔钢丝增强聚氨酯导管,在15%(n=18/120)的产妇中第一次尝试时没有成功,而导管“B”,即多孔钢丝增强聚酰胺尼龙混合物硬膜外导管的第一次尝试失败率只有0.8%(n=1/120)(P< 0.0001)。在接受导管“A”的分娩患者中记录了25次额外的硬膜外穿刺操作,而在接受导管“B”的产妇中只记录到了1次(P<0.0001)。麻醉包“B”中使用的硬膜外导管的弯曲刚度是“A”中使用导管弯曲刚度的两倍(弯曲刚度导管“A”为0.64±0.04N  ·  mm  2  ,弯曲刚度导管“B”为1.28±0.20N  ·  mm  2  ,P =0.0038),并且麻醉包“A”中的针和硬膜外导管形成的角度小于麻醉包“B”中形成的角度(麻醉包“A”为14.17±1.72°,麻醉包“B”为21.83±1.33°,P =0.0036),两种麻醉包和相应硬膜外导管形成的角度平均差异为7.66°。

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结论

与使用多孔钢丝增强聚酰胺尼龙混合硬膜外导管相比,无法置入单端孔钢丝增强聚氨酯导管的发生率更高。硬膜外针和导管形态特征的变化可能在决定分娩硬膜外镇痛的成功建立中起关键作用。

原始文献来源

Carlo Pancaro, Jasmine Purtell, Dana LaBuda  ,  et al.     Difficulty in Advancing Flexible Epidural Catheters When     Establishing Labor Analgesia: An Observational Open-Label Randomized Trial[J].     (Anesth Analg 2021 07 01;133(1))  .



Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial

Abstract

Background:   While flexible epidural catheters reduce the risk of paresthesia and intravascular cannulation, they may be more challenging to advance beyond the tip of a Tuohy needle. This may increase placement time, number of attempts, and possibly complications when establishing labor analgesia. This study investigated the ability to advance flexible epidural catheters through different epidural needles from 2 commonly used, commercially available, epidural kits. Methods:   We hypothesized that the multiorifice wire-reinforced polyamide nylon blend epidural catheters will have a higher rate of successful first attempt insertion than the single-end hole wire-reinforced polyurethane catheters for the establishment of labor analgesia. The primary outcome was a difference in proportions of failure to advance the epidural catheter between the 2 epidural kits and was tested by aχ  2   test. Two-hundred forty epidural kits were collected (n=120/group) for 240 laboring patients requesting epidural analgesia in this open-label clinical trial from November 2018 to September 2019. Two-week time intervals were randomized for the exclusive use of 1 of the 2 kits in this study, where all patients received labor analgesia through either the flexible epidural catheter“A”or the flexible epidural catheter“B.” Engineering properties of the equipment used were then determined. Results:   Flexible epidural catheter“A,” the single-end hole wire-reinforced polyurethane catheter, did not advance at the first attempt in 15% (n=18 of 120) of the parturients compared to 0.8% (n=1 of 120) of the catheter“B,”the multiorifice wire-reinforced polyamide nylon blend epidural catheter (P <0.0001). Twenty-five additional epidural needle manipulations were recorded in the laboring patients who received catheter“A,”while 1 epidural needle manipulation was recorded in the parturients who received catheter“B”(P <0.0001). Bending stiffness of the epidural catheters used from kit“B”was twice the bending stiffness of the catheters used from kit“A”(bending stiffness catheters“A”0.64±0.04 N·mm2 versus bending stiffness catheters“B”1.28±0.20 N·mm2, P =0.0038), and the angle formed by the needle and the epidural catheter from kit“A”was less acute than the angle formed from kit“B” (kit“A”14.17±1.72°versus kit“B”21.83±1.33°, P=0.0036), with a mean difference of 7.66°between the 2 kits’ angles. Conclusions:  The incidence of an inability to advance single-end hole wire-reinforced polyurethane catheter was higher compared to the use of multiorifice wire-reinforced polyamide nylon blend epidural catheter. Variation of morphological features of epidural needles and catheters may play a critical role in determining the successful establishment of labor epidural analgesia.

                                    

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关键词:
观察性,麻醉包,硬膜,导管,柔性,标签,增强

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