Department of Obstetrics and Gynecology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China.
Department of the Fourth School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Contraception. 2024 Jul;135:110439. doi: 10.1016/j.contraception.2024.110439. Epub 2024 Mar 27.
The majority of intrauterine devices (IUDs) inserted in China are tailless, requiring intrauterine manipulations for removal and causing pain. This study aimed to investigate the analgesic efficacy of lidocaine injection into a novel disposable injectable cervical dilator for IUD removal procedures.
A double-blinded, placebo-controlled, randomized clinical trial was conducted with women aged 18-65 years old requesting outpatient IUD removal. The study randomly assigned participants to either lidocaine (injecting 5 ml of 2% lidocaine into the injectable cervical dilator) or placebo (injecting 5 ml of normal saline into the device) group. All participants received a standardized paracervical block. The primary outcome was pain reported during IUD removal on a 100 mm Visual Analog Scale (VAS). Intention-to-treat were conducted to evaluate the analgesic effectiveness of injecting lidocaine into the injectable cervical dilators.
We enrolled seventy-four eligible participants (37 in lidocaine group and 37 in placebo group). The results showed that the median intraoperative VAS score in the lidocaine group was lower than the placebo group (30.0 mm [IQR 20.0-46.0, n = 37] vs 46.0 mm [IQR 30.0-55.0, n = 37], p = 0.01. In subgroup analyses, among participants with IUD removal and without uterine manipulation and additional procedures, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (15.0 mm [IQR 10.0-27.5, n = 8] vs 20.0 mm [IQR 20.0-40.0, n = 6]), p = 0.28). Among participants with an IUD removal necessitating intrauterine manipulations and without additional procedures, showing lower intraoperative VAS scores in lidocaine group (25.0 mm [IQR 15.0-40.5, n = 17]) compared to placebo group (46.0 mm [IQR 38.5-50.0, n = 23]), p < 0.01. Among participants with additional procedures in addition to IUD removal, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (41.0 mm [IQR 32.5-57.5, n = 12] vs 45.0 mm [IQR 22.5-69.0, n = 8]), p = 0.97).
Injecting lidocaine into the novel disposable injectable cervical dilator for cervix dilation can significantly reduce pain during an IUD removal, particularly in patients necessitating intrauterine manipulations during IUD removal.
When we have to perform intrauterine manipulations to remove an IUD, surgical pain and narrow cervical canal undoubtedly affect the implementation of the procedure. Injecting lidocaine into the injectable cervical dilator can achieve local anesthesia while dilating the cervix, and might reduce the choice of general anesthesia for IUD removal.
中国大多数宫内节育器（IUD）为无尾式，需要进行宫内操作才能取出，从而引起疼痛。本研究旨在探讨利多卡因注射到新型一次性可注射宫颈扩张器中用于 IUD 取出术的镇痛效果。
这是一项双盲、安慰剂对照、随机临床试验，纳入年龄在 18-65 岁之间、要求门诊取出 IUD 的女性。研究将参与者随机分配到利多卡因（向可注射宫颈扩张器中注射 5ml 2%利多卡因）或安慰剂（向装置中注射 5ml 生理盐水）组。所有参与者均接受了标准化的宫颈旁阻滞。主要结局是使用 100mm 视觉模拟量表（VAS）评估 IUD 取出过程中的疼痛。采用意向治疗来评估向可注射宫颈扩张器中注射利多卡因的镇痛效果。
我们共纳入了 74 名符合条件的参与者（利多卡因组 37 名，安慰剂组 37 名）。结果显示，利多卡因组术中 VAS 评分中位数低于安慰剂组（30.0mm[IQR 20.0-46.0，n=37]vs 46.0mm[IQR 30.0-55.0，n=37]，p=0.01）。在亚组分析中，在仅需进行 IUD 取出而无需宫内操作和其他操作的参与者中，利多卡因组和安慰剂组的术中 VAS 评分无统计学差异（15.0mm[IQR 10.0-27.5，n=8]vs 20.0mm[IQR 20.0-40.0，n=6]，p=0.28）。在需要宫内操作且无需其他操作的 IUD 取出参与者中，利多卡因组的术中 VAS 评分较低（25.0mm[IQR 15.0-40.5，n=17]），而安慰剂组较高（46.0mm[IQR 38.5-50.0，n=23]），p<0.01。在除 IUD 取出外还需要其他操作的参与者中，利多卡因组和安慰剂组的术中 VAS 评分无统计学差异（41.0mm[IQR 32.5-57.5，n=12]vs 45.0mm[IQR 22.5-69.0，n=8]，p=0.97）。
向新型一次性可注射宫颈扩张器中注射利多卡因可显著减轻 IUD 取出过程中的疼痛，尤其是在需要在 IUD 取出过程中进行宫内操作的患者中。
当我们必须进行宫内操作以取出 IUD 时，手术疼痛和狭窄的宫颈管无疑会影响手术的实施。向可注射宫颈扩张器中注射利多卡因可以在扩张宫颈的同时实现局部麻醉，并且可能会减少因 IUD 取出而选择全身麻醉的情况。
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