Paracervical Block for Pain Associated With Laminaria Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pain After Placement of Laminaria (100 mm Visual Analog Scale)
研究概览
简要总结
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
详细描述
Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between the ages of 18-49 years
- •Desiring surgical termination of pregnancy or surgical management of a fetal demise
- •Treatment plan involves cervical preparation with laminaria
- •Participant able to provide informed consent in English and willing to participate in the study
排除标准
- •Unable to read/speak/understand English
- •Contraindications to receiving lidocaine
研究组 & 干预措施
Paracervical Block with lidocaine
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
干预措施: Paracervical Block with lidocaine (Drug)
Sham paracervical block
A sham block will be done prior to the placement of laminaria using a capped needle
干预措施: Sham paracervical block (Drug)
结局指标
主要结局
Pain After Placement of Laminaria (100 mm Visual Analog Scale)
时间窗: Measured within 10 seconds after placement of laminaria
We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
次要结局
- Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)(15 minutes post-operatively)
- Paracervical or Sham Block Pain(Within 10 seconds after receiving paracervical or sham block)
研究者
Reni Soon
Assistant Professor
University of Hawaii