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Abstract
Objective
To evaluate the analgesic effect of self-administered vaginal 2% lidocaine in-situ gel in pain relief during copper intrauterine device (IUD) insertion in women with previous caesarean delivery only.
Methods
A Randomised, double-blind, placebo-controlled trial (Clinicaltrials.gov: NCT03166111) included reproductive-aged women who previously delivered only by caesarean section (CS) requesting Copper IUD insertion. Eligible women were recruited and randomised (1:1) to lidocaine in-situ gel vs. placebo. Each woman was supplied by a syringe filled with five ml lidocaine or placebo in-situ gel to be self-administered vaginally ten minutes before insertion. The primary outcome was the difference in pain scores during IUD placement using a 10-cm Visual Analogue Scale (VAS).
Results
The final analysis included 216 women (n = 108 in each arm). Women in the Lidocaine in situ gel group were more likely to report statistically significant lower pain scores during vulsellum application, uterine sound placement, and during IUD placement [Mean difference (95%CI) = 2.04 (1.66–2.42), 2.62 (2.20–3.04), and 2.57 (2.12–3.01), respectively, p = 0.0001]. A significantly lower IUD insertion score indicating easier insertion was reported in the lidocaine group (p = 0.004). Similarly, the duration of IUD insertion was significantly shorter in the lidocaine group (p = 0.008). There was a higher level of satisfaction in the lidocaine group (5.92 vs. 3.34) in the placebo group (p = 0.0001).
Conclusions
Self-administered vaginal lidocaine in-situ gel 10 min before copper IUD insertion is effective in pain reduction in women with previous caesarean delivery only.
摘要
目的：评价自制阴道用2%利多卡因凝胶在有剖宫产史妇女放置宫内节育器时的镇痛效果。
方法：一项随机、双盲、安慰剂对照试验（Clinical Trictures . gov:NCT 03166111）包括既往剖腹产（CS）现要求植入含铜宫内节育器的育龄妇女。招募符合条件的女性, 随机（1:1）用利多卡因凝胶与安慰剂。每位女性在植入器械前10分钟, 通过一个装有5ml利多卡因或安慰剂凝胶的注射器进行阴道给药。主要结果是观察放置宫内节育器期间用10厘米视觉模拟量表（VAS）的疼痛评分差异。
结果：最终分析包括216名女性（每组108人）。利多卡因凝胶组的妇女更有可能报告在放置宫颈钳、子宫探头装置和放置宫内节育器期间疼痛评分显著降低[平均差异(95%置信区间)分别为2.04(1.66–2.42)、2.62(2.20–3.04)和2.57(2.12–3.01), p= 0.0001]。利多卡因组的宫内节育器植入VAS评分明显较低, 表明植入器械更容易(p= 0.004)。同样, 利多卡因组放置宫内节育器的时间明显缩短(p =0.008)。利多卡因组的满意度高于安慰剂组(分别为5.92和3.34)(p= 0.0001)。
结论：在放置含铜宫内节育器前10分钟给予阴道利多卡因凝胶, 可有效减轻有剖宫产史的妇女的疼痛。
Disclosure statement
The authors declare that they have no competing interests.
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