Abbas Ahmed M, Abd Ellah Noura H, Hosny Maryt A, Abdellah Mohamed S, Ali Mohammed K
Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt.
Eur J Contracept Reprod Health Care. 2021 Apr;26(2):132-138. doi: 10.1080/13625187.2020.1868427. Epub 2021 Feb 4.
To evaluate the analgesic effect of self-administered vaginal 2% lidocaine gel in pain relief during copper intrauterine device (IUD) insertion in women with previous caesarean delivery only.
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 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).
The final analysis included 216 women ( = 108 in each arm). Women in the Lidocaine 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, = 0.0001]. A significantly lower IUD insertion score indicating easier insertion was reported in the lidocaine group ( = 0.004). Similarly, the duration of IUD insertion was significantly shorter in the lidocaine group ( = 0.008). There was a higher level of satisfaction in the lidocaine group (5.92 vs. 3.34) in the placebo group ( = 0.0001).
Self-administered vaginal lidocaine gel 10 min before copper IUD insertion is effective in pain reduction in women with previous caesarean delivery only.
仅对有剖宫产史的女性，评估自行阴道使用2%利多卡因凝胶在放置宫内节育器（IUD）过程中缓解疼痛的效果。
一项随机、双盲、安慰剂对照试验（Clinicaltrials.gov：NCT03166111）纳入了仅既往有剖宫产史且要求放置铜IUD的育龄女性。符合条件的女性被招募并随机（1:1）分为利多卡因凝胶组和安慰剂组。在放置IUD前10分钟，为每位女性提供一支装有5毫升利多卡因或安慰剂原位凝胶的注射器，供其自行经阴道给药。主要结局是使用10厘米视觉模拟量表（VAS）评估放置IUD过程中的疼痛评分差异。
最终分析纳入了216名女性（每组108名）。利多卡因凝胶组的女性在使用宫颈钳、放置子宫探针以及放置IUD过程中，更有可能报告疼痛评分在统计学上显著更低[平均差异（95%CI）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]。利多卡因组报告的IUD插入评分显著更低，表明插入更容易（P = 0.004）。同样，利多卡因组的IUD插入持续时间显著更短（P = 0.008）。利多卡因组的满意度更高（5.92对安慰剂组的3.34）（P = 0.0001）。
在放置铜IUD前10分钟自行经阴道使用利多卡因凝胶，对仅既往有剖宫产史的女性减轻疼痛有效。
