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局部用利多卡因-丙胺卡因乳膏与利多卡因浸润用于阴道分娩后会阴撕裂修补术时的疼痛缓解:随机临床试验

Topical lidocaine-prilocaine cream versus lidocaine infiltration for pain relief during repair of perineal tears after vaginal delivery: randomized clinical trial.

作者信息

Abbas Ahmed M, Abdel Hafiz Hamida A, Abdelhafez Aya M, Michael Armia, Ismail Alaa M

机构信息

a Department of Obstetrics and Gynecology, Faculty of Medicine , Assiut University , Assiut, Egypt.

b Department of Obstetrics & Gynecological Nursing, Faculty of Nursing , Assiut University , Assiut, Egypt.

出版信息

J Matern Fetal Neonatal Med. 2019 Jul;32(13):2182-2187. doi: 10.1080/14767058.2018.1428304. Epub 2018 Jan 31.

Abstract

OBJECTIVE

The current study aims to compare the analgesic effect of lidocaine-prilocaine (LP) cream with lidocaine infiltration during repair of perineal tears after vaginal delivery.

MATERIALS AND METHODS

A single center open-labeled randomized clinical trial was carried out in a tertiary University Hospital between October 2016 and May 2017 (Clinical Trials.Gov: NCT02883179). We included parous women, who delivered at gestational age >37 weeks with first- or second-degree perineal tears. The participants were randomized in a 1:1 ratio to either lidocaine infiltration (Group I); or application of LP cream (Group II) for pain relief during perineal repair. The primary outcome was the difference in mean pain score during perineal repair. Secondary outcomes included the participants' satisfaction, the need for additional anesthesia, the duration of perineal repair, and the rate of adverse effects of both medications.

RESULTS

The study included 144 participants randomized to both groups. The mean pain score during perineal repair was significantly lower in the LP cream group (3.86 ± 1.59) than the lidocaine infiltration group (5.99 ± 1.47) [p = .001]. The duration of repair was significantly shorter in the LP group than the lidocaine infiltration group (6.37 ± 3.68 versus 8.17 ± 2.75 min, respectively, p = .001). The need for additional anesthesia was quite similar in both groups (p = .371). More women in the LP cream group were satisfied than the other group with statistical significant difference (76.4 versus 30.6%, p = .000). No difference between side effects in both groups (p = .171) Conclusions: Topical application of lidocaine-prilocaine cream is an effective analgesic during repair of perineal tears with no harmful side effects.

摘要

目的

本研究旨在比较利多卡因-丙胺卡因(LP)乳膏与利多卡因浸润在阴道分娩后会阴撕裂修补术中的镇痛效果。

材料与方法

2016年10月至2017年5月在一家三级大学医院进行了一项单中心开放标签随机临床试验(ClinicalTrials.gov:NCT02883179)。我们纳入了孕周>37周且有一或二度会阴撕裂的经产妇。参与者按1:1比例随机分为利多卡因浸润组(第一组);或应用LP乳膏组(第二组),用于会阴修补术中缓解疼痛。主要结局是会阴修补术中平均疼痛评分的差异。次要结局包括参与者的满意度、额外麻醉的需求、会阴修补的持续时间以及两种药物的不良反应发生率。

结果

该研究纳入了144名随机分为两组的参与者。LP乳膏组会阴修补术中的平均疼痛评分(3.86±1.59)显著低于利多卡因浸润组(5.99±1.47)[p = 0.001]。LP组的修补持续时间显著短于利多卡因浸润组(分别为6.37±3.68分钟和8.17±2.75分钟,p = 0.001)。两组额外麻醉的需求相当相似(p = 0.371)。LP乳膏组中对修补满意的女性比另一组更多,差异有统计学意义(76.4%对30.6%,p = 0.000)。两组不良反应之间无差异(p = 0.171)结论:局部应用利多卡因-丙胺卡因乳膏在会阴撕裂修补术中是一种有效的镇痛方法,且无有害副作用。

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