Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women eligible and scheduled for office hysteroscopic placement of essure devices
排除标准
- •Planned secondary procedures
- •Lidocaine allergy
- •Repeat procedures
研究组 & 干预措施
Lidocaine paracervical block
5cc 1% lidocaine injection in each paracervical region
干预措施: Lidocaine paracervical block (Drug)
Saline placebo injection
5cc Normal Saline injection in each paracervical region
干预措施: Normal Saline (Drug)
结局指标
主要结局
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
时间窗: During Procedure
This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.
次要结局
未报告次要终点