Abbas Ahmed M, Abdellah Mohamed S, Khalaf Mohamed, Bahloul Mustafa, Abdellah Noura H, Ali Mohamed K, Abdelmagied Ahmed M
Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4.
The objective was to investigate the analgesic effect of cervical lidocaine-prilocaine (LP) cream in alleviating pain during copper T380A intrauterine device (IUD) insertion among parous women.
We conducted a randomized, double-blind, placebo-controlled trial at Assiut Women's Health Hospital, Egypt, from October 2015 to April 2016 of parous women desiring copper IUD insertion. We randomized the subjects in a 1:1 ratio to LP cream or placebo. Seven minutes prior to IUD insertion, women received 2 ml of LP cream or placebo to the anterior cervical lip, followed by 2 ml placed in the cervical canal using a Q-tip applicator. The study end point was the subjects' self-reported pain using a 10-cm visual analog scale (VAS) during cervical tenaculum placement, sound insertion, IUD insertion and 5 min postprocedure. We considered a 2-cm difference in VAS scores between study groups as clinically significant. Also, the difference in the ease of insertion score using a 10-cm VAS with 0=very easy insertion and 10=terribly difficult insertion was assessed.
The study included 120 women (n=60 in each group). LP cream reduces the median VAS pain scores during tenaculum placement (2 vs. 4), sound insertion (3 vs. 6) and IUD insertion (3 vs. 6.5) with p=.0001 at all steps. A lower ease of insertion score was also determined among LP women (2.5±0.98 vs. 4.5±2.7, p=.001). Participants reported no side effects.
Use of cervical LP cream prior to copper T380A IUD insertion may alleviate the IUD insertion pain among parous women.
Cervical LP cream could be effective as an analgesic prior to copper T380A IUD insertion with no side effects. Further studies are needed to assess the women's satisfaction from lying with a speculum in place for 7 min while waiting for the cream to be effective.
本研究旨在探讨宫颈利多卡因-丙胺卡因（LP）乳膏在减轻经产妇放置铜T380A宫内节育器（IUD）过程中疼痛方面的镇痛效果。
2015年10月至2016年4月，我们在埃及阿斯尤特妇女健康医院对希望放置铜IUD的经产妇进行了一项随机、双盲、安慰剂对照试验。我们将受试者按1:1的比例随机分为LP乳膏组或安慰剂组。在放置IUD前7分钟，女性在前宫颈唇涂抹2ml LP乳膏或安慰剂，然后用棉签将2ml药物置于宫颈管内。研究终点是受试者在宫颈钳放置、探条插入、IUD插入及术后5分钟时，使用10厘米视觉模拟量表（VAS）自我报告的疼痛程度。我们认为研究组间VAS评分相差2厘米具有临床意义。此外，还评估了使用10厘米VAS的插入难易程度评分差异，0表示插入非常容易，10表示插入极其困难。
该研究纳入了120名女性（每组60名）。LP乳膏在宫颈钳放置（2 vs. 4）、探条插入（3 vs. 6）和IUD插入（3 vs. 6.5）过程中均降低了VAS疼痛评分中位数，所有步骤的p值均为0.0001。LP组女性的插入难易程度评分也较低（2.5±0.98 vs. 4.5±2.7，p = 0.001）。参与者均未报告有副作用。
在放置铜T380A IUD前使用宫颈LP乳膏可能会减轻经产妇放置IUD时的疼痛。
宫颈LP乳膏在放置铜T380A IUD前可作为一种有效的镇痛药，且无副作用。需要进一步研究评估女性在等待乳膏起效时，使用窥器7分钟的满意度。
