A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
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.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Missed primary endpoint
paper pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group PMID 24012096 ↗
paper 36.7 (median 36) in the placebo group (p=.8). PMID 24012096 ↗
paper did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. PMID 24012096 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 120 mg | Other |
Indications
No indication recorded.