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孕中期流产前放置海藻棒时宫颈旁阻滞的随机对照试验

Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

作者信息

Soon Reni, Tschann Mary, Salcedo Jennifer, Stevens Katelyn, Ahn Hyeong Jun, Kaneshiro Bliss

机构信息

Department of Obstetrics, Gynecology & Women's Health and the Office of Biostatistics & Quantitative Health Sciences, John A. Burns School of Medicine, University of Hawaii, Honolulu, Hawaii.

出版信息

Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149.

Abstract

OBJECTIVE

To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion.

METHODS

In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm.

RESULTS

From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2-39] compared with 54 mm [interquartile range 27-61], P=.01, 95% CI -47.0 to -4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78-100] compared with 70 mm [interquartile range 44-90], P=.05, 95% CI 0.0-37.0).

CONCLUSION

Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02454296.

摘要

目的

评估宫颈旁阻滞在孕中期流产前插入渗透扩张器时减轻疼痛的效果。

方法

在这项双盲随机试验中,41名在孕中期流产前接受海藻棒插入的女性,分别接受了含18毫升1%利多卡因和2毫升碳酸氢钠的宫颈旁阻滞或假阻滞。这些女性的孕周在14至23又6/7周之间。主要结局是插入海藻棒后即刻的疼痛。女性使用100毫米视觉模拟量表评估疼痛程度。次要结局包括插入过程中其他时间点的疼痛评估以及对疼痛控制的总体满意度。为了在海藻棒插入后即刻检测出25毫米的疼痛差异,设定α为0.05,检验效能为80%,我们计划每组招募20名患者。

结果

2015年5月至2015年12月期间,20名女性接受了宫颈旁阻滞,21名接受了假阻滞。两组在人口统计学特征上相似,包括产次、手术流产史和放置海藻棒的数量。宫颈旁阻滞减轻了插入海藻棒后的疼痛(中位数评分13毫米[四分位间距2 - 39],而假阻滞组为54毫米[四分位间距27 - 61],P = 0.01,95%可信区间 - 47.0至 - 4.0)。接受宫颈旁阻滞的女性在整个海藻棒插入过程中对总体疼痛控制的满意度也更高(中位数评分95毫米[四分位间距78 - 100],而假阻滞组为70毫米[四分位间距44 - 90],P = 0.05,95%可信区间0.0至37.0)。

结论

宫颈旁阻滞在减轻海藻棒插入疼痛方面有效。此外,宫颈旁阻滞提高了患者在放置海藻棒过程中对疼痛控制的总体满意度。

临床试验注册

ClinicalTrials.gov,NCT02454296。

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