A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion

Conditions
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Pain

Intervention / Treatment
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* Drug: 2% lidocaine gel
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. | Drug: Placebo gel<br>* Inert gel x 1<br>|
| Experimental: Study Group<br>Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. | Drug: 2% lidocaine gel<br>* 120mg lidocaine x 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Score During IUD Insertion | 0 to 100 mm visual analog scale, higher values represent more pain. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain measurement, Intrauterine devices, Lidocaine