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临床试验/NCT03572439
NCT03572439已完成不适用

Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing (Anesthetized Area to Non-anesthetized Area Versus Non-anesthetized to Anesthetized Area)

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
The upper sensory block level to cold

研究概览

简要总结

Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. A variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. In addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. Not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. Another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. This lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. Considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. The objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • •patients who request and have no contraindications to receive epidural analgesia
  • •capable of understanding and signing the written informed consent
  • •have no language barrier to respond to the level of sensory block assessment
  • •have no conditions that could compromise their sensitivity to cold.

排除标准

  • •patients who refuse to sign consent
  • •epidural analgesia is contraindicated

研究组 & 干预措施

Cephalad to caudal

Active Comparator

Sensory block level check using ice, moving from cephalad to caudal

干预措施: Sensory block level check using ice (Diagnostic Test)

Caudal to cephalad

Active Comparator

Sensory block level check using ice, moving from caudal to cephalad

干预措施: Sensory block level check using ice (Diagnostic Test)

结局指标

主要结局

The upper sensory block level to cold

时间窗: 1 hour

The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold

The lower sensory block level to cold

时间窗: 1 hour

The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold

次要结局

  • Patient satisfaction(20 minutes)
  • The lower sensory block level to cold(2 hours)
  • The upper sensory block level to cold(2 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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