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罗哌卡因单独使用与罗哌卡因联合舒芬太尼用于硬膜外分娩镇痛的比较。

Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia.

作者信息

Wang Xian, Xu Shiqin, Qin Xiang, Li Xiaohong, Feng Shan-Wu, Liu Yusheng, Wang Wei, Guo Xirong, Shen Rong, Shen Xiaofeng, Wang Fuzhou

机构信息

From the Department of Anesthesiology, Nanjing Maternity and Child Health Care Hospital Affiliated to Nanjing Medical University, Nanjing, China (XW, SX, XQ, XL, SWF, YL, WW, XS, FW); Institute of Pediatrics, Nanjing Maternity and Child Health Care Hospital Affiliated to Nanjing Medical University, Nanjing, China (XG, RS); and Division of Neuroscience, The Bonoi Academy of Science and Education, Chapel Hill, NC, USA (FW).

出版信息

Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882.

Abstract

To compare the analgesic efficacy and safety of the sole local anesthetic ropivacaine with the combination of both local anesthetic ropivacaine and opioidergic analgesic sufentanil given epidurally on the labor pain control.After institutional review board approval and patient consent, a total of 500 nulliparas requesting epidural labor analgesia were enrolled and 481 eventually were randomized into 2 groups: a sole local anesthetic group (ropivacaine 0.125%) and a combination of local anesthetic and opioidergic analgesic group (0.125% ropivacaine + 0.3 μg/mL sufentanil). After the test dose, a 10-mL epidural analgesic solution was given in a single bolus, followed by intermittent bolus injection of 10 to 15 mL of the solution. The primary outcome was the analgesic efficacy measured using Numerical Rating Scale (NRS) of pain. Other maternal and infant variables were evaluated as secondary outcomes.A total of 346 participants completed the study. The median NRS pain score during the 1st stage of labor was significantly lower in the combination group 2.2 (interquartile range [IQR]: 1.8-2.7) comparing to the sole local analgesic group 2.4 (IQR: 2.0-2.8) (P < 0.0001). No significant difference was observed in NRS pain score prior epidural analgesia and during the 2nd stage of labor. Patients in both groups rated same satisfaction of analgesia. Patients in the sole local analgesic group experienced fewer side effects than those in the combination group (37.7% vs 47.2%, P = 0.082). The individual analgesia-related cost in the sole local analgesic group was less ($5.7 ± 2.06) than that in the combination group ($9.76 ± 3.54) (P < 0.0001). The incidence of 1-minute Apgar ≤ 7 was lower in the sole local analgesic group 2 (1.2%) than the combination group 10 (5.5%) (P = 0.038). No difference was found between other secondary outcomes.The sole local anesthetic ropivacaine produces a comparable labor analgesic effect as the combination of both local anesthetic ropivacaine and opioidergic analgesic sufentanil at different stages of labor (ΔNRS = 0.2) but the former has less side effects, lower cost, and less incidence of lower 1-minute Apgar scoring. These results imply the necessity of a systematic reevaluation of epidural labor analgesia with sole local anesthetics against combination regimens of local anesthetics and other opioids.

摘要

为比较单纯局部麻醉药罗哌卡因与局部麻醉药罗哌卡因和阿片类镇痛药舒芬太尼联合硬膜外给药用于分娩镇痛的镇痛效果及安全性。经机构审查委员会批准并获得患者同意后,共纳入500例要求硬膜外分娩镇痛的初产妇,最终481例被随机分为2组:单纯局部麻醉药组(0.125%罗哌卡因)和局部麻醉药与阿片类镇痛药联合组(0.125%罗哌卡因+0.3μg/mL舒芬太尼)。给予试验剂量后,一次性推注10 mL硬膜外镇痛溶液,随后间歇性推注10至15 mL该溶液。主要结局是使用疼痛数字评定量表(NRS)测量的镇痛效果。其他母婴变量作为次要结局进行评估。共有346名参与者完成了研究。与单纯局部镇痛组的2.4(四分位间距[IQR]:2.0 - 2.8)相比,联合组在第一产程期间的NRS疼痛评分中位数显著更低,为2.2(IQR:1.8 - 2.7)(P < 0.0001)。在硬膜外镇痛前和第二产程期间的NRS疼痛评分未观察到显著差异。两组患者对镇痛的满意度相同。单纯局部镇痛组患者的副作用比联合组更少(37.7%对47.2%,P = 0.082)。单纯局部镇痛组的个体镇痛相关费用更低(5.7±2.06美元),低于联合组(9.76±3.54美元)(P < 0.0001)。单纯局部镇痛组1分钟阿氏评分≤7的发生率低于联合组,分别为2例(1.2%)和10例(5.5%)(P = 0.038)。在其他次要结局方面未发现差异。单纯局部麻醉药罗哌卡因在分娩不同阶段产生的分娩镇痛效果与局部麻醉药罗哌卡因和阿片类镇痛药舒芬太尼联合使用相当(NRS差值 = 0.2),但前者副作用更少、成本更低且1分钟阿氏评分较低的发生率更低。这些结果表明有必要对单纯局部麻醉药用于硬膜外分娩镇痛与局部麻醉药和其他阿片类药物联合方案进行系统的重新评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/550c/4985418/6902e4b54d00/medi-94-e1882-g001.jpg

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