利多卡因-丙胺卡因乳膏与注射利多卡因用于外阴活检的比较: 随机对照试验

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利多卡因-丙胺卡因乳膏与注射利多卡因用于外阴活检的比较: 随机对照试验

翻译:唐剑  编辑:冯玉蓉  审校:曹莹

背景:比较应用5%利多卡因-丙胺卡因乳膏或注射1%利多卡因后外阴活检患者的疼痛控制效果。

方法计划招募需要进行外阴活检的患者106名,两组患者分别使用利多卡因-丙胺卡因乳膏 (活检前10分钟使用,n=53) 或1% 利多卡因直接注射 (活检开始前1分钟,n=53)。使用100mm视觉模拟量表在三个时间点分别记录患者疼痛情况: 基线水平、麻醉后和活检后。主要评价指标是记录患者最高疼痛评分。次要指标分别是记录活检时的疼痛评分、患者体验以及耐受情况和可接受性。在控制基线水平时外阴疼痛的情况下,使用线性回归比较两组间的主要结果指标。

结果:试验时间为2018年10月至2019年3月,38 例患者完成知情同意并随机分组。参与者平均年龄为60岁女性。组间大多数特征相似。利多卡因-丙胺卡因乳膏组患者19例,利多卡因注射组18例。利多卡因-丙胺卡因乳膏组的最高疼痛评分中位数为20.0mm,利多卡因注射组为56.5mm。控制基线水平疼痛时,利多卡因-丙胺卡因乳膏组的最高疼痛评分比利多卡因注射组低25.7mm (95% CI [-45.1 ~-6.3]; P<0.01)。随机接受利多卡因-丙胺卡因乳膏的患者体验明显优于接受注射利多卡因的患者 (体验评分中位数2.0mm vs 17.0mm; P =0.02)。

结论:与注射利多卡因相比,外阴活检前使用利多卡因-丙胺卡因乳膏可降低最大疼痛评分,并且活检时患者体验更好。单独使用利多卡因-丙胺卡因乳膏是外阴活检时的合理选择。

文献来源: Williams LK,  Weber JM, Pieper C,et al. Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial.[J].OBSTETRICS & GYNECOLOGY, 2020,02;135(2)

Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial

Abstract

OBJECTIVE: To compare pain control during vulvar biopsy after either application of 5% lidocaine– prilocaine cream or injection of 1% lidocaine.

METHODS: In a single-site randomized trial, patients who needed vulvar biopsy on a non–hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine–prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N5106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019.

RESULTS: From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine–prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine– prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine–prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [245.1 to 26.3]; P,.01). Patients randomized to lidocaine–prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P5.02).

CONCLUSION: Lidocaine–prilocaine cream before vulvar biopsy resulted in a lower maximum pain score and a significantly better patient rating of the biopsy experience when compared with lidocaine injection. Lidocaine– prilocaine cream, alone, is a reasonable option to use for vulvar biopsy

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