Paracervical Block Versus No Paracervical Block During IUD Insertion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Score as Assessed by a Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
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 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
排除标准
- •Women with current pelvic inflammatory disease (PID)
- •Women who are not good candidates for an IUD
- •Patients who have a Lidocaine allergy
研究组 & 干预措施
Paracervical block
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
干预措施: Lidocaine (Drug)
Paracervical block
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
干预措施: Intrauterine device (IUD) (Device)
No analgesia
IUD placement with no analgesia.
干预措施: No analgesia (Other)
No analgesia
IUD placement with no analgesia.
干预措施: Intrauterine device (IUD) (Device)
结局指标
主要结局
Pain Score as Assessed by a Visual Analogue Scale (VAS)
时间窗: baseline (about 30 seconds after insertion of the speculum)
The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
Pain Score as Assessed by a Visual Analogue Scale
时间窗: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)
The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
次要结局
未报告次要终点
研究者
Pamela Berens
Professor
The University of Texas Health Science Center, Houston