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利多卡因-丙胺卡因乳膏用于子宫输卵管造影术镇痛的随机双盲对照研究。

Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study.

作者信息

Arnau Baldomero, Jovell Esther, Romero Marino, Gonzalez Manuela, Esteba Lola, Garcia Araceli

机构信息

Department of Obstetrics and Gynaecology, Consorci Sanitari de Terrassa, Crta. Torrebonica s/n, 08227 Terrassa, Barcelona, Spain.

Department of Epidemiology, Consorci Sanitari de Terrassa, Barcelona, Spain.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.

DOI:10.1016/j.ejogrb.2014.09.035
PMID:25445103
Abstract

OBJECTIVE

The efficacy of lidocaine-prilocaine cream (EMLA(®)) analgesia in the practice of hysterosalpingography is controversial. This study provides new drill results and a new method of application in terms of mode, time and place. The aim of the paper is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream applied to the uterine cervix for reducing pain during hysterosalpingography.

STUDY DESIGN

A randomized, double blinded, controlled study set in the general gynaecology clinic of a university teaching hospital between September 2012 and June 2013. One hundred successive patients programmed to undergo hysterosalpingography were randomized to either 3 ml of EMLA (50) cream or 3 ml of placebo (50), placed endocervically and exocervically, 10 min before hysterosalpingography. Patients' intensity of pain was assessed in four steps: at baseline (speculum application), after application of Pozzi tenaculum and cannula on the uterine cervix, during cervical traction and after contrast medium injection, using a 10-cm Visual Analogue Scale (VAS) immediately after the procedure. The most painful step was also identified. VAS was administered again at one-month follow-up visit.

TRIAL REGISTRATION

NCT01303614.

RESULTS

The contrast medium injection was the most painful step of hysterosalpingography in both groups (EMLA 3.96, placebo 4.54, 95%CI: -0.481 to 1.641). No differences were found between the two groups (P=0.281) during this step. When comparing the VAS scale after the application of Pozzi tenaculum and cannula (EMLA 1.06, placebo 3.34, 95%CI: 1.495-3.065) and after cervical traction (EMLA 2.54, placebo 3.46, 95%CI: 0.034-1.806), significantly less pain was experienced by the EMLA group than the placebo group: P=0.000 and P=0.042, respectively.

CONCLUSION

Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation with tenaculum and cannula and during cervical traction, but did not reduce pain during injection of contrast that was the most painful step.

摘要

目的

利多卡因-丙胺卡因乳膏(复方利多卡因乳膏(EMLA®))用于子宫输卵管造影术中镇痛的效果存在争议。本研究在方式、时间和地点方面提供了新的研究结果及新的应用方法。本文旨在探讨将含25mg利多卡因和25mg丙胺卡因的5%乳膏涂抹于子宫颈以减轻子宫输卵管造影术期间疼痛的效果。

研究设计

一项随机、双盲、对照研究,于2012年9月至2013年6月在一所大学教学医院的普通妇科门诊进行。连续100例计划接受子宫输卵管造影术的患者被随机分为两组,一组在子宫输卵管造影术前10分钟宫颈内和宫颈外涂抹3ml复方利多卡因乳膏(50例),另一组涂抹3ml安慰剂(50例)。通过以下四个步骤评估患者的疼痛强度:基线时(放置窥器)、在宫颈上应用波齐子宫钳和套管后、宫颈牵引期间以及注射造影剂后,在操作结束后立即使用10厘米视觉模拟评分法(VAS)进行评估。还确定了最疼痛的步骤。在1个月的随访时再次进行VAS评分。

试验注册号

NCT01303614。

结果

两组中,注射造影剂均是子宫输卵管造影术中最疼痛的步骤(复方利多卡因乳膏组评分为3.96,安慰剂组评分为4.54,95%置信区间:-0.481至1.641)。在此步骤中,两组之间未发现差异(P = 0.281)。比较应用波齐子宫钳和套管后(复方利多卡因乳膏组评分为1.06,安慰剂组评分为3.34,95%置信区间:1.495 - 3.065)以及宫颈牵引后(复方利多卡因乳膏组评分为2.54,安慰剂组评分为3.46,95%置信区间:0.034 - 1.806)的VAS评分,复方利多卡因乳膏组的疼痛明显低于安慰剂组,P值分别为0.000和0.042。

结论

在子宫输卵管造影术前10分钟在宫颈内和宫颈外局部应用复方利多卡因乳膏可显著减轻使用子宫钳和套管进行宫颈操作期间以及宫颈牵引期间的疼痛,但不能减轻最疼痛步骤即注射造影剂期间的疼痛。

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