BACKGROUND:Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Clinical trials have found misoprostol and nonsteroidal drugs to be ineffective (Am J Obstet Gynecol 2006;195:1272-1277, Hum Reprod 2011;26:323-329, Hum Reprod 2007;22:2647-2652). One study suggested that 2% lidocaine gel decreased pain; however, study design problems limit its validity (Brit J Fam Plann 1996;22:177-180). We tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo. STUDY DESIGN: We planned a randomized, double-blinded clinical trial of 200 women. We placed 2% lidocaine gel or placebo in the cervix prior to uterine sounding. Participants rated pain by marking a 100-mm visual analogue scale at four time points. RESULTS: We randomized 200 participants and placed 197 IUDs. Pain was greatest at uterine sounding and similar between groups: placebo group mean 51.6 mm (SD 25), lidocaine group mean 55.5 mm (SD 30, p=.33). Stratified analyses accounting for parity showed no treatment effect. Multivariable analyses identified longer time since last pregnancy, lower parity and higher anticipated pain as predictors of pain during sounding, and dysmenorrhea and the levonorgestrel IUD as additional predictors during IUD insertion. CONCLUSIONS: Intracervical 2% lidocaine gel does not decrease IUD insertion pain. Understanding predictors of increased pain may help providers with preprocedure counseling.
RCT Entities:
BACKGROUND:Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Clinical trials have found misoprostol and nonsteroidal drugs to be ineffective (Am J Obstet Gynecol 2006;195:1272-1277, Hum Reprod 2011;26:323-329, Hum Reprod 2007;22:2647-2652). One study suggested that 2% lidocaine gel decreased pain; however, study design problems limit its validity (Brit J Fam Plann 1996;22:177-180). We tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo. STUDY DESIGN: We planned a randomized, double-blinded clinical trial of 200 women. We placed 2% lidocaine gel or placebo in the cervix prior to uterine sounding. Participants rated pain by marking a 100-mm visual analogue scale at four time points. RESULTS: We randomized 200 participants and placed 197 IUDs. Pain was greatest at uterine sounding and similar between groups: placebo group mean 51.6 mm (SD 25), lidocaine group mean 55.5 mm (SD 30, p=.33). Stratified analyses accounting for parity showed no treatment effect. Multivariable analyses identified longer time since last pregnancy, lower parity and higher anticipated pain as predictors of pain during sounding, and dysmenorrhea and the levonorgestrel IUD as additional predictors during IUD insertion. CONCLUSIONS: Intracervical 2% lidocaine gel does not decrease IUD insertion pain. Understanding predictors of increased pain may help providers with preprocedure counseling.
Authors: Luis Bahamondes; Diana Mansour; Christian Fiala; Andrew M Kaunitz; Kristina Gemzell-Danielsson Journal: J Fam Plann Reprod Health Care Date: 2013-09-27
Authors: Laureen M Lopez; Alissa Bernholc; Yanwu Zeng; Rebecca H Allen; Deborah Bartz; Paul A O'Brien; David Hubacher Journal: Cochrane Database Syst Rev Date: 2015-07-29