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

Not Applicable

Completed

Conditions: Pain

Interventions: Drug: Placebo
Drug: Lidocaine

Registration Number: NCT01534520

Lead Sponsor: University of Pittsburgh

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Intravaginal placebo gel	Placebo	Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Group 1: Intravaginal 2% lidocaine gel	Lidocaine	Intravaginal insertion of 4mL of 2% lidocaine gel

Primary Outcome Measures

Name	Time	Method
Change in Pain From Baseline to IUD Insertion	change in pain score from baseline (before IUD insertion) to time of 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).

Secondary Outcome Measures

Name	Time	Method
Percentage of IUDs Considered by Physicians Easy to Insert	Directly after IUD insertion	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.
To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD	After inserting the gel but prior to IUD insertion	Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale
Need for Pain Medication up to 7 Days	7 days post-insertion	Number of women taking pain medication for at least one day following IUD insertion