NCT02738203: Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Summary

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.

Timeline

Start: 2016-06-01
Primary completion: 2017-10-19
Completion: 2017-10-19

Outcome

Missed primary endpoint

paper Self-administered lidocaine gel at least 15 minutes before intrauterine device insertion does not appear to reduce pain compared with placebo PMID 30444982 ↗

Publications

Conti JA, Lerma K, Schneyer RJ, Hastings CV, Blumenthal PD, Shaw KA. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Feb;220(2):177.e1-177.e7. doi: 10.1016/j.ajog.2018.11.1085. Epub 2018 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	2 %	Other
Subject	Lidocaine	Other / unclassified	10 ml	Other

Indications

No indication recorded.