Division of Complex Family Planning, Department of Obstetrics, Gynecology, and Reproductive Sciences, and the Center on Gender Equity and Health, University of California, San Diego, La Jolla, the Division of Complex Family Planning, Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, and the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California.
Obstet Gynecol. 2022 Aug 1;140(2):234-242. doi: 10.1097/AOG.0000000000004862. Epub 2022 Jul 6.
To compare pain scores during office dilation and aspiration between low-volume and high-volume paracervical block of the same dose.
We conducted a multi-site, randomized, single-blind, placebo-controlled trial from October 2018 to December 2020. We randomized participants presenting for office dilation and aspiration under minimal sedation stratified by procedural indication (induced abortion vs early pregnancy loss) to a 20-mL buffered 1% lidocaine paracervical block or a 40-mL buffered 0.5% lidocaine paracervical block, both with two units of vasopressin in a standardized technique. To detect a 15-mm or greater difference in pain at the time of cervical dilation with 80% power and a two-sided alpha of 0.05, a total of 104 participants was required. The study was also powered to detect a 20-mm or greater difference in pain at the time of cervical dilation within each stratum (induced abortion and early pregnancy loss). The primary outcome was pain with cervical dilation on a 100-mm visual analog scale in the overall cohort. Secondary outcomes included pain with cervical dilation within each stratum. We used a Wilcoxon rank-sum test to compare median pain scores between groups.
We enrolled 114 participants. There was no difference in median pain scores between low-volume and high-volume groups during dilation (62 mm vs 59 mm, P=.94), aspiration (69.5 mm vs 70 mm, P=.47), postprocedure (25 mm vs 25 mm, P=.76), or overall (60 mm vs 60 mm, P=.23). Stratified by indication, there were no significant differences in scores at any time point between the low-volume and high-volume paracervical block groups. There was decreased overall pain in patients with induced abortion who received the higher volume paracervical block, though this did not reach statistical significance (67.5 mm vs 60.5 mm, P=.08). Pain during paracervical block administration was similar between groups (55 mm vs 45 mm, P=.24) and there was no difference in occurrence of side effects (P=.63).
We found no difference in pain with cervical dilation among participants who received the low-volume compared with high-volume paracervical block when studied alone.
ClinicalTrials.gov, NCT03636451.
比较相同剂量的低容量和高容量经宫颈旁阻滞用于门诊扩张和抽吸时的疼痛评分。
我们于 2018 年 10 月至 2020 年 12 月进行了一项多中心、随机、单盲、安慰剂对照试验。我们将因诱导性流产或早期妊娠丢失而接受门诊扩张和抽吸术的参与者按程序指征（诱导性流产与早期妊娠丢失）分层，随机分为 20mL 缓冲 1%利多卡因经宫颈旁阻滞或 40mL 缓冲 0.5%利多卡因经宫颈旁阻滞，两种方案均采用标准化技术加入两单位血管加压素。为了在 80%的功效和双侧 0.05 的 α 水平下检测到宫颈扩张时疼痛的 15mm 或更大差异，需要 104 名参与者。该研究还具有在每个分层（诱导性流产和早期妊娠丢失）中检测到宫颈扩张时疼痛的 20mm 或更大差异的能力。主要结局是在整个队列中，采用 100mm 视觉模拟量表评估宫颈扩张时的疼痛。次要结局包括每个分层中宫颈扩张时的疼痛。我们使用 Wilcoxon 秩和检验比较组间的中位数疼痛评分。
我们共纳入 114 名参与者。在扩张过程中，低容量组和高容量组的中位数疼痛评分无差异（62mm 比 59mm，P=0.94），抽吸过程中（69.5mm 比 70mm，P=0.47），术后（25mm 比 25mm，P=0.76）或总体（60mm 比 60mm，P=0.23）。按指征分层，在任何时间点，低容量和高容量经宫颈旁阻滞组的评分均无显著差异。接受高容量经宫颈旁阻滞的因诱导性流产患者的总体疼痛减轻，尽管这未达到统计学意义（67.5mm 比 60.5mm，P=0.08）。两组经宫颈旁阻滞时的疼痛（55mm 比 45mm，P=0.24）和不良反应的发生情况无差异（P=0.63）。
当单独研究时，与接受高容量经宫颈旁阻滞相比，接受低容量经宫颈旁阻滞的参与者在宫颈扩张时的疼痛无差异。
ClinicalTrials.gov，NCT03636451。
