Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale
研究概览
简要总结
This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion.
The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Can sign informed consent
- •Healthy pregnant females
- •Weight over 45kg
- •Seeking abortion by dilation and evacuation in the second trimester of pregnancy
- •Gestational age 14-24 weeks confirmed by clinic ultrasound
排除标准
- •Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent
- •Known allergy or previous reaction to ibuprofen or other NSAID
研究组 & 干预措施
Intrauterine Lidocaine
The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
干预措施: Lidocaine (Drug)
Intrauterine Saline
Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale
时间窗: Immediately following laminaria insertion
次要结局
- Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale(24-48 hours after laminaria insertion)