At a glance
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Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Vaginal 2% Lidocaine and Surgical Lubricant Jelly for IUD Insertion. Completed, enrolled 220 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly