Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
研究概览
简要总结
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18 and older
- •Intrauterine pregnancy ≥16 weeks gestation
- •English speaking competency
- •Willing and able to sign consent forms
- •Agree to comply with study procedures
排除标准
- •Women less than 18 years of age
- •IV conscious sedation
- •Known allergy to study medication (lidocaine)
- •Any women not meeting inclusion criteria above will be excluded from participation
研究组 & 干预措施
Self-administered Gel
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
干预措施: Lidocaine Gel (2%) (Drug)
Paracervical Block
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
干预措施: Lidocaine Paracervical Block (1%) (Drug)
结局指标
主要结局
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
时间窗: Intraoperative; Immediately (0-30 seconds) following cervical dilation
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
次要结局
- Overall Pain Measured by Visual Analogue Scale(Postoperative; Assessed once 10 minutes after procedure)
- Speculum Placement Measured by Visual Analogue Scale(Intraoperative; Immediately following speculum placement)
- Anticipated Pain Measured by Visual Analogue Scale(Preoperative; 30 minutes prior to procedure)
- Baseline Pain Measured by Visual Analogue Scale(Immediately prior to procedure)