Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Completed · Phase 3

Conditions studied: IUD Insertion

In brief

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.

Key facts

Study ID

NCT02738203

Run by

Stanford University

People needed

220

Starts

2016-06-01

Expected to finish

2017-10-19

Last updated by the study team

2019-06-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

You may not qualify if…

• Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.

Where it is running

• Stanford Gynecology Clinic — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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