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临床试验/NCT03140293
NCT03140293已完成早期 1 期

A Randomized Trial to Determine if Local Anesthesia Decreases Pain Perception in Women Undergoing Chorionic Villus Sampling

Angela Bianco1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
Angela Bianco
入组人数
120
试验地点
1
主要终点
Visual Analog Scale (VAS) Pain perception scores VAS ()

研究概览

简要总结

Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. Multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.

详细描述

Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). There are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap.

The study will be offered to women at <13 weeks gestation, with a singleton fetus who are seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. This study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure.

This trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. The investigators do not know if there is a difference in perception for topical or injectable. If the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • <13 week gestation
  • Singleton gestations undergoing CVS

排除标准

  • Multiple gestations
  • More than one attempt of needle insertion
  • Allergy or hypersensitivity to local anesthesia

研究组 & 干预措施

Lidocaine Injection

Active Comparator

Injection of lidocaine which is given prior to chorionic villus sampling

干预措施: Lidocaine injection (Drug)

Gebauer Ethyl Chloride Spray

Experimental

Topical anesthesia will be Gebauer Ethyl Chloride sprayed continuously from 3 - 7 seconds from a distance of 3-9 inches until the skin turns white (not frosting the skin) as per Gebauer package insert instructions.

干预措施: Gebauer Ethyl Chloride Spray (Drug)

结局指标

主要结局

Visual Analog Scale (VAS) Pain perception scores VAS ()

时间窗: day 1

Procedure pain perception score as measured by the visual analog scale. By means of analysis of the receiver operating characteristic curves on a 100mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm

Verbal Rating Scale (VRS)

时间窗: day 1

Procedure pain perception score as measured by the Verbal Rating Scale. 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain, 5=most severe pain imaginable

次要结局

未报告次要终点

研究者

发起方
Angela Bianco
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Angela Bianco

MD

Icahn School of Medicine at Mount Sinai

研究点 (1)

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