Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women (LIVIIN)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial|
- Change in Pain From Baseline to IUD Insertion [ Time Frame: 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).
- To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD [ Time Frame: 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
- Percentage of IUDs Considered by Physicians Easy to Insert [ Time Frame: 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.
- Need for Pain Medication up to 7 Days [ Time Frame: 7 days post-insertion ]Number of women taking pain medication for at least one day following IUD insertion
|Study Start Date:||June 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Group 1: Intravaginal 2% lidocaine gel
Intravaginal insertion of 4mL of 2% lidocaine gel
Intravaginal insertion of 4mL 2% lidocaine gel
Placebo Comparator: Group 2: Intravaginal placebo gel
Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534520
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Rachel B Rapkin, MD||University of Pittsburgh|