Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women

Study Overview
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Brief Summary
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This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

Detailed Description
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Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion. This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion. If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.

Official Title
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Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) No history of pregnancy in the last 6 weeks Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics Prior failed IUD insertion Prior IUD use Use of narcotic or benzodiazepine medication within the last 24 hours U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Intravaginal 2% lidocaine gel<br>Intravaginal insertion of 4mL of 2% lidocaine gel | Drug: Lidocaine<br>* Intravaginal insertion of 4mL 2% lidocaine gel<br>* Other names: Lidocaine Hydrochloride;|
| Placebo Comparator: Group 2: Intravaginal placebo gel<br>Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) | Drug: Placebo<br>* KY Jelly<br>* Other names: water based lubricant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain From Baseline to IUD Insertion | To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel). | change in pain score from baseline (before IUD insertion) to time of IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale | After inserting the gel but prior to IUD insertion | 
| Percentage of IUDs Considered by Physicians Easy to Insert | The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group. | Directly after IUD insertion | 
| Need for Pain Medication up to 7 Days | Number of women taking pain medication for at least one day following IUD insertion | 7 days post-insertion | 

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