A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Completed · Not applicable · Has a placebo group
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01292447
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 150
- Starts
- 2011-02-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2020-09-02
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- plans for IUD insertion for contraception or abnormal uterine bleeding;
- 18 to 49 years of age;
- reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;
- no prior IUD use;
- not taken analgesics or anxiolytics in the previous 24 hours;
- not taken misoprostol prior to IUD insertion;
- the ability and are willing to give informed consent;
- speaks English or Spanish.
You may not qualify if…
- any contraindication to IUD placement;
- allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;
- chronic narcotic/benzodiazepine/barbiturate use within the past year.
Where it is running
- Women's Primary Care Center/Women and Infants' Hospital — Providence, Rhode Island, United States
- Womens Primary Care Center — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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