Family Planning Services and Research, Department of Obstetrics and Gynecology, Stanford School of Medicine, Stanford, California.
Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485.
To evaluate whether a 12-mL paracervical block is noninferior to a 20-mL block in reducing pain with osmotic dilator insertion.
In this single-blinded noninferiority trial, we randomized individuals undergoing insertion of osmotic dilators before second-trimester abortion to receive either a 12-mL or 20-mL 1% lidocaine paracervical block. The primary outcome was pain immediately after insertion of osmotic dilators. Prespecified secondary outcomes included pain with paracervical block administration, overall pain, and side effects, with 88 participants being required for a noninferiority margin of 15 mm on a 100-mm visual analog scale assuming an SD of 28. We analyzed data using Wilcoxon rank sum, χ2, and t tests and performed analysis of variance to account for repeated measures. Secondary analysis included multivariable regression to explore potential confounders.
From January 2018 to October 2020, of 232 eligible individuals, 174 were approached and 96 randomized (48 participants to each group); 91 were available for analysis (45: 12 mL, 46: 20 mL). Group demographics were similar, with a mean gestation of 21 weeks and four osmotic dilators placed. The 12-mL paracervical block was noninferior to the 20-mL paracervical block for pain with osmotic dilator insertion with a difference in means of -1.36 (95% CI -12.56 to 9.85) favoring 12 mL. Median pain scores after dilator placement were 47 mm (interquartile range 22-68) and 50 mm (interquartile range 27-67) in 12-mL compared with 20-mL paracervical block, respectively (P=.81). No difference was seen in median pain at baseline, with paracervical block administration, postprocedure or with overall pain or experience. At least one lidocaine-related side effect occurred in 4% of participants in the 12-mL group compared with 13% for those receiving 20 mL (P=.15), with metallic taste, ringing in ears, and lightheadedness being most common.
A 12-mL paracervical block is noninferior to a 20-mL block for pain reduction with osmotic dilator insertion.
ClinicalTrials.gov, NCT03356145.
评估 12ml 宫颈旁阻滞是否与 20ml 阻滞在减轻渗透扩张器插入引起的疼痛方面无差异。
在这项单盲非劣效性试验中，我们将接受渗透扩张器插入前宫颈旁阻滞的个体随机分为接受 12ml 或 20ml 1%利多卡因宫颈旁阻滞。主要结局是渗透扩张器插入后立即发生的疼痛。预先规定的次要结局包括宫颈旁阻滞给药时的疼痛、总疼痛和副作用，假设标准差为 28，在 100mm 视觉模拟量表上有 15mm 的非劣效性边界，需要 88 名参与者。我们使用 Wilcoxon 秩和检验、卡方检验和 t 检验进行数据分析，并进行方差分析以考虑重复测量。二次分析包括多变量回归以探索潜在的混杂因素。
从 2018 年 1 月至 2020 年 10 月，共有 232 名符合条件的个体，其中 174 名被接触，96 名被随机分组（每组 48 名）；91 名可供分析（45 名：12ml，46 名：20ml）。组间人口统计学特征相似，平均妊娠 21 周，放置 4 个渗透扩张器。12ml 宫颈旁阻滞在渗透扩张器插入疼痛方面不劣于 20ml 宫颈旁阻滞，差值为-1.36（95%CI-12.56 至 9.85），有利于 12ml。与 20ml 宫颈旁阻滞相比，放置扩张器后 12ml 组的中位疼痛评分分别为 47mm（四分位距 22-68）和 50mm（四分位距 27-67）（P=.81）。在基线时、宫颈旁阻滞给药时、术后或总体疼痛或体验时，均未见中位疼痛有差异。12ml 组有 4%的参与者发生至少一种与利多卡因相关的副作用，而接受 20ml 组有 13%（P=.15），最常见的副作用是金属味、耳鸣和头晕。
与 20ml 阻滞相比，12ml 宫颈旁阻滞在减轻渗透扩张器插入引起的疼痛方面无差异。
ClinicalTrials.gov，NCT03356145。
