A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Status: | Archived |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | February 2011 |
End Date: | February 2012 |
A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials