Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Ramat Gan、以色列
- Sheba medical center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
• Informed consent
- Women with a gestational age of 12-24 weeks by last menstrual period.
Exclusion Criteria:
• CRL assesed by ultrasound as <10 weeks
- Clinical Uterine size >24 weeks
- Fetus Bi Parietal Diameter > 50 mm
- Known amide allergy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:lidocaine spray group
|
will local application of lidocaine to the cervix alleviate pain of laminaria insertion
|
|
安慰剂比较:安慰剂组
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain immediately after inserton of first laminaria
大体时间:immediately after first laminaria insertion
|
Women's reported VAS pain score immediately after the insertion of the first laminaria.
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immediately after first laminaria insertion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E
大体时间:After speculum removal, 15 minutes after speculum insertion and before D&E
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Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D&E
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After speculum removal, 15 minutes after speculum insertion and before D&E
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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