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临床试验/NCT06456177
NCT06456177已完成不适用

Assessment of Nociception in Obstetric Patients During Epidural Analgesia

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月30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
Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Nociception Level (NOL) index

研究概览

简要总结

Introduction and aim: Nociception monitors have been used to assess pain management in anesthetized patients. The investigators set out to evaluate whether Nociception Level (NOL) monitor (PMD-200 monitor with NOL technology , (Medasense Biometrics Ltd. Ramat Gan, Israel) yields reliable readings during labor, and whether the derived NOL index will be associated with Visual analogue scale (VAS) subjective level of pain before and after the onset of epidural analgesia.

Methods:

Following approval by the intuitional review board No 0056-21-CMC, thirty parturients scheduled for epidural analgesia due to labor pains will be included in this prospective study, after informed consent for participation in the study will be obtained. NOL monitoring device will be connected to the subject finger. Epidural analgesia will be performed as per institutional standards. Data of VAS and NOL index will be collected once a minute. The association between VAS and NOL before and after the onset of adequate analgesia will be evaluated.

详细描述

Introduction:

Epidural analgesia is the most effective method of labor pain relief to this day. The lumbar epidural analgesia aims to induce a sensory block from T10 to L1, while at the same time facilitating the motor action of the lower limbs (L2-L5), thereby enabling the continued cooperation of the mother in the birth process.

Pain assessment is crucial for pain management and to date relies almost solely on subjective monitoring using self-assessment scales of the subject, which can be affected by personality, behavior, and psychological characteristics. Objective tools to measure pain have been developed. They rely on the changes in the balance between sympathetic and parasympathetic activity and include the heart rate variability, blood pressure, skin electrical conductivity and the vasomotor reflex and the electroencephalogram pupil. Nociception represents the integrated response to painful stimuli including the neural, hormonal and behavioral activity. Combination of multiple nociception-related parameters yielded stronger associations with the noxious stimuli compared with each parameter alone.

The PMD-200 monitor with NOL technology (Medasense Biometrics Ltd. Ramat Gan, Israel) is a novel, propriety, monitoring device based on a combination of nociception related physiological variables including heart rate, heart rate variability, photo-plethysmographic waveforms, skin conductance, and their time derivative. Based on a random forest model, the device generates the Nociception level (NOL) index, displayed as a scale from 0-100 with 0 representing no nociception and 100 representing extreme nociception. A NOL level of less than 25 arbitrary units is associated with adequate analgesia in patients under general anesthesia.

So far, the objective assessment of pain has been restricted mainly to patients who were under general anesthesia. Data in conscious patients is scant . The study design is to evaluate how nociception changes in the awake patients, and especially, how its changes following blockade of the painful stimuli. Study population parturients who will be scheduled to receive epidural analgesia for labor. This allow us to study the nociceptive level index during uterine contractions before and after the onset of epidural analgesia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parturient
  • Age between 20-45 years
  • Present pregnancy istheir second
  • Singleton births
  • Under Epiduarl analgesia

排除标准

  • Age younger than 20 years or older than 45 years
  • First pregnancy
  • Multiple birth

结局指标

主要结局

Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Nociception Level (NOL) index

时间窗: 60 minutes

The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by monitoring the Nociception Level (NOL) index displayed as a scale from 0-100 with 0 representing no nociception and 100 representing extreme nociception, when higher scores mean a worse outcome.

Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Visual Analog Scale (VAS)

时间窗: 60 minutes

The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by reporting the Visual Analog Scale (VAS) displayed as a scale from 1-10, with 0 representing no nociception and 10 representing extreme nociception, when higher scores mean a worse outcome

次要结局

未报告次要终点

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Grach

Director of outpatient pain medicine clinic

Carmel Medical Center

研究点 (1)

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