Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan; and the Department of Obstetrics and Gynecology, the Program in Women's Oncology, Division of Research, Department of Obstetrics and Gynecology, and the Program in Women's Oncology, Department of Obstetrics and Gynecology, Women & Infants Hospital, Alpert Medical School of Brown University, Providence, Rhode Island.
Obstet Gynecol. 2020 Mar;135(3):609-614. doi: 10.1097/AOG.0000000000003710.
To evaluate the effects of buffered lidocaine on pain scores during vulvar biopsy.
We conducted a double-blind, randomized controlled trial, using prefilled, sequentially numbered, randomized syringes to infiltrate either 3 mL of buffered or nonbuffered lidocaine before vulvar biopsy. The primary outcome was a pain score marked on a 100-mm visual analog scale during infiltration. Secondary outcomes included pain scores after the procedure and change from baseline to infiltration. Participants were recruited to detect a clinically meaningful 15-mm difference in pain scores between groups. Sample size was calculated based on the null hypothesis that the mean pain score would be the same in women treated with buffered lidocaine as in those treated with nonbuffered placebo based on prior studies. Categorical data were compared by Fisher exact test, and continuous data were compared between groups by t-test or Wilcoxon rank sum test.
From July 2015 to April 2018, 129 participants were randomized to one of two groups: nonbuffered lidocaine or buffered lidocaine. One hundred twenty-five were analyzed (nonbuffered n=62, buffered n=63). Four patients were excluded. The majority of participants were non-Hispanic white women with a mean age of 59 years. There was no difference in the primary outcome of pain during infiltration with a mean pain score of 35.8 mm in the buffered lidocaine group compared with 42.2 in the nonbuffered lidocaine group (mean difference -6.4; 95% CI -18.4 to 5.6; P=.3 by Wilcoxon rank sum test). There was also no difference in secondary outcomes of pain over the entire procedure (mean difference -0.3, 95% CI -9.7 to 9.2; P=.7) or change in pain from baseline to infiltration (mean difference -6.9, 95% CI -18.4 to 4.7; P=.2).
There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups.
ClinicalTrials.gov, NCT02698527.
评估缓冲利多卡因对外阴活检过程中疼痛评分的影响。
我们进行了一项双盲、随机对照试验，使用预先填充的、顺序编号的、随机注射器，在进行外阴活检前，分别注射 3 毫升缓冲或非缓冲利多卡因。主要结局是在浸润过程中用 100 毫米视觉模拟量表标记的疼痛评分。次要结局包括术后疼痛评分以及从基线到浸润的变化。招募参与者以检测两组之间疼痛评分有意义的 15 毫米差异。根据基于先前研究的假设，即接受缓冲利多卡因治疗的女性的平均疼痛评分与接受非缓冲安慰剂治疗的女性相同，计算了样本量。分类数据采用 Fisher 精确检验比较，组间连续数据采用 t 检验或 Wilcoxon 秩和检验比较。
从 2015 年 7 月至 2018 年 4 月，共有 129 名参与者被随机分配到两组之一：非缓冲利多卡因或缓冲利多卡因。125 名患者进行了分析（非缓冲组 62 例，缓冲组 63 例）。排除了 4 名患者。大多数参与者是非西班牙裔白人女性，平均年龄为 59 岁。浸润时疼痛的主要结局无差异，缓冲利多卡因组平均疼痛评分为 35.8 毫米，非缓冲利多卡因组为 42.2 毫米（平均差值-6.4；95%CI-18.4 至 5.6；Wilcoxon 秩和检验 P=.3）。整个手术过程中的疼痛（平均差值-0.3，95%CI-9.7 至 9.2；P=.7）或从基线到浸润时疼痛的变化（平均差值-6.9，95%CI-18.4 至 4.7；P=.2）也无差异。
缓冲和非缓冲利多卡因组在外阴活检浸润过程中的疼痛评分无差异。
ClinicalTrials.gov，NCT02698527。
