Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)
研究概览
简要总结
This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.
详细描述
Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies
- •Signed consent to participate in the trial
- •Women between the ages of 18 and 45 years
- •Gestational ages 15 - 24 weeks
排除标准
- •Multiple gestation
- •Refusal to participate in the trial
- •Known hypersensitivity to lidocaine
- •Amniocentesis during this pregnancy
- •Amnioinfusion/amnioreduction where the procedure is likely to be prolonged
研究组 & 干预措施
Local Anesthesia
Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum.
干预措施: Local Anesthesia (Drug)
Placebo-Normal saline
Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum.
干预措施: Placebo Group (Drug)
结局指标
主要结局
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)
时间窗: Immediately following amniocentesis procedure
Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)
次要结局
- Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)(Immediately following amniocentesis procedure)