Does lidocaine gel produce an effective analgesia prior to copper IUD insertion? Randomized clinical trial

摘要

Background: IUD is a small contraceptive device, often containing either copper or levonorgestrel, which is inserted into the uterus. Objective of present study was to determine if lidocaine gel prior to intrauterine device (IUD) insertion decreases pain with the insertion procedure among multiparous women choosing the copper T380A-IUD. Methods: It is a randomized double-blind controlled trial carried out at Assiut Women's Health Hospital, Assiut, Egypt. Parous women eligible for Copper IUD insertion attended the Family Planning Clinic were recruited and randomized in a 1:1 ratio to lidocaine gel or placebo. Two ml of the study medications were topically placed on the cervix 3 minutes before IUD insertion. The primary outcome was the difference in pain scores using a 10-cm Visual Analogue Scale (VAS) during IUD insertion. We considered a 1.5 cm difference in VAS scores between study groups as clinically significant. Results: One hundred women consented to participate and randomized either to group I: lidocaine group or group II: placebo group. Both groups were homogenous in baseline socio-demographic data. There was significant difference in mean pain scores for IUD placement between women who received lidocaine gel and placebo at two steps of insertion (at vulsellum application and at uterine sounding) while the rest of steps show no statistical significant difference (p=0.000). There were no statistical significant differences between both group as regard the ease of insertion, the duration of insertion and the satisfaction score after the procedure (p0.05). Conclusions: This study depicts that the use of lidocaine gel prior to copper IUD insertion in multiparous women could partially reduce the pain during tenaculum placement and uterine sounding.