Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Pain immediately after inserton of first laminaria
研究概览
简要总结
To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo.
a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation & evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D&E 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Informed consent
- •Women with a gestational age of 12-24 weeks by last menstrual period.
排除标准
- •• CRL assesed by ultrasound as <10 weeks
- •Clinical Uterine size >24 weeks
- •Fetus Bi Parietal Diameter > 50 mm
- •Known amide allergy
研究组 & 干预措施
lidocaine spray group
干预措施: Lidocaine (Drug)
placebo arm
干预措施: placebo comparator (Other)
结局指标
主要结局
Pain immediately after inserton of first laminaria
时间窗: immediately after first laminaria insertion
Women's reported VAS pain score immediately after the insertion of the first laminaria.
次要结局
- Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E(After speculum removal, 15 minutes after speculum insertion and before D&E)
研究者
Dr. Avi Shina MD
Doctor
Sheba Medical Center
