Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Median Visual Analogue Score Measuring Pain
研究概览
简要总结
The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 18 -50 years
- •A negative urine pregnancy test and clinically unlikely to be pregnant
- •Seeking an intrauterine device for any indication
- •Willing and able to sign an informed consent in English
排除标准
- •History of a prior IUD successful insertion
- •Previous failed insertion of an IUD
- •Known copper allergy
- •Known levonorgestrel allergy
- •Known lidocaine allergy
- •Current cervicitis
- •Pelvic Inflammatory Disease (PID) within 3 months
- •Pregnancy within six weeks prior to IUD insertion
- •Uterine anomaly or distortion of the uterine cavity
- •Use of any other pain medication within 6 hours prior to IUD insertion
- •Use of misoprostol within 24 hours prior to IUD insertion
研究组 & 干预措施
Paracervical Block
干预措施: Lidocaine (Drug)
结局指标
主要结局
Median Visual Analogue Score Measuring Pain
时间窗: 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure
We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points: 1. Speculum placement 2. Tenaculum placement 3. Paracervical block administration(if subject is in this arm) 4. IUD insertion 5. Five minutes post procedure
次要结局
未报告次要终点
研究者
Jessica Kiley
Assistant Professor
Northwestern University