A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive
that may be underutilized due to fear of pain during insertion. Although providers frequently
prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no
evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled
trials have been shown to be effective in reducing pain during IUD insertion. While many
women tolerate IUD insertion well, others have moderate to severe pain. This double-blind
randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2%
lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is
that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced
pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a
15 mm difference on the VAS with our sample size. Other data to be collected include
information regarding age, BMI, obstetric history, lactation status, time since pregnancy or
delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated
pain levels, insertion characteristics (time, difficulty, complications), side effects, and
satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily
administered option for pain control will be available to providers and patients.