跳至主要内容
临床试验/NCT05187962
NCT05187962已完成不适用

Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch

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: 2021年12月21日最近更新:
适应症

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
Upper sensory block level: pinprick test

研究概览

简要总结

Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA Physical Status Classification II and III parturients
  • Requested and received a labour epidural
  • Capable of consenting to the study
  • Have no language barrier which may obfuscate the sensory block assessment
  • Are receiving programmed intermittent epidural boluses (PIEB) for maintenance analgesia, which is the Mount Sinai Hospital default maintenance regimen

排除标准

  • Medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch
  • Epidurals performed under a combined spinal-epidural (CSE) or dural puncture epidural (DPE) technique
  • Epidurals with a documented unintentional dural puncture
  • Inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural

结局指标

主要结局

Upper sensory block level: pinprick test

时间窗: 5 minutes

The upper sensory block level to pinprick is defined as the dermatome at which there is an altered sharp sensation without complete sensitivity loss.

Lower sensory block level: ice test

时间窗: 5 minutes

The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception.

Lower sensory block level: pinprick test

时间窗: 5 minutes

The lower sensory block level to pinprick, defined as the dermatome at which there is a complete loss of sharp sensation.

Sensory block level: soft touch test

时间窗: 5 minutes

The sensory block level using soft touch is defined as the dermatome below which the patient can feel a light touch.

Upper sensory block level: ice test

时间窗: 5 minutes

The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss.

次要结局

  • Motor block score using Bromage score(5 minutes)

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)

Loading locations...

相似试验