NCT02738203

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• IUD Insertion

Interventions

Type	Name	Description
DRUG	Vaginal 2% Lidocaine	Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
DRUG	Surgical Lubricant Jelly	Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-10-19
• Completion: 2017-10-19
• First posted: 2016-04-14
• Last updated: 2019-06-06
• Results posted: 2018-09-18

Locations

1 site across 1 country: United States