Department of Obstetrics and Gynecology, and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, and the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.
Obstet Gynecol. 2020 Feb;135(2):311-318. doi: 10.1097/AOG.0000000000003660.
To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine.
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 (N=106) 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.
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 [-45.1 to -6.3]; 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; P=.02).
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.
ClinicalTrials.gov, NCT03654417.
比较 5%利多卡因-丙胺卡因乳膏和 1%利多卡因注射用于外阴活检时的止痛效果。
在单站点随机试验中，从妇科肿瘤学诊所招募需要在外阴非毛发区域进行活检的患者，比较利多卡因-丙胺卡因乳膏（至少在活检前 10 分钟涂抹）和利多卡因注射（至少在活检前 1 分钟注射）。计划每组（N=106）招募 53 名参与者。使用 100 毫米视觉模拟量表在三个时间点记录疼痛：基线、麻醉后和活检后。主要结局是记录到的最高疼痛评分。次要结局为活检时的疼痛评分、患者体验以及耐受性和可接受性。线性回归用于比较两组之间的主要结局，同时控制基线外阴疼痛。便利分析于 2019 年 3 月进行。
从 2018 年 10 月至 2019 年 3 月，有 38 名患者完成了知情同意并被随机分组。参与者为中位年龄 60 岁的女性。两组的大多数特征相似。利多卡因-丙胺卡因组 19 人，利多卡因注射组 18 人。利多卡因-丙胺卡因组的最高疼痛评分中位数为 20.0 毫米，利多卡因注射组为 56.5 毫米。控制基线疼痛后，利多卡因-丙胺卡因组的最高疼痛评分比利多卡因注射组低 25.7 毫米（95%CI[-45.1 至-6.3]；P<.01）。与接受注射利多卡因的患者相比，随机分配到利多卡因-丙胺卡因的患者体验明显更好（中位数体验评分 2.0 毫米 vs 17.0 毫米；P=.02）。
与利多卡因注射相比，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，并显著改善患者对活检的体验评分。单独使用利多卡因-丙胺卡因乳膏是外阴活检的合理选择。
ClinicalTrials.gov，NCT03654417。
