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临床试验/NCT01534520
NCT01534520已完成不适用

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

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Change in Pain From Baseline to IUD Insertion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group 1: Intravaginal 2% lidocaine gel

Experimental

Intravaginal insertion of 4mL of 2% lidocaine gel

干预措施: Lidocaine (Drug)

Group 2: Intravaginal placebo gel

Placebo Comparator

Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Pain From Baseline to IUD Insertion

时间窗: 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).

次要结局

  • Percentage of IUDs Considered by Physicians Easy to Insert(Directly after IUD insertion)
  • To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD(After inserting the gel but prior to IUD insertion)
  • Need for Pain Medication up to 7 Days(7 days post-insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Achilles

Assistant Professor

University of Pittsburgh

研究点 (1)

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