跳至主要内容
临床试验/NCT02097017
NCT02097017已完成4 期

Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Lidocaine (Drug)

placebo arm

Placebo Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Avi Shina MD

Doctor

Sheba Medical Center

研究点 (1)

Loading locations...

相似试验