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临床试验/NCT03252301
NCT03252301Unknown不适用

Assessment of Pain in Surgical Patient by PMD 200

Meir Hospital, Kfar Saba, Israel0 个研究点目标入组 25 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
主要终点
pain level estimation by 1-100 scale by non invasive finger sensor

研究概览

简要总结

The trial will estimate post-operative pain management in elective surgical patients using the PMD-200 device. The device measures physiological parameters by placing a non-invasive sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level will be estimated before surgery (baseline), after surgery and during administration of parenteral analgesia. Treatment and analgesia will be given according to clinical considerations and standard ward protocols. The device measurements won't influence the treatment.

详细描述

  1. Background The key to adequate pain management is assessing its presence, duration and severity, identifying those who require intervention, and evaluating the treatment efficacy. Pain relates to both the noxious input, via peripheral nerves, and to central modulation, thereby, integrating different modalities such as affect, experience or personality. Nociception refers to the peripheral and central nervous system (CNS) processing of information about the internal or external environment, as generated by activation of nociceptors. Typically, noxious stimuli, including tissue injury, activate nociceptors that are present in peripheral structures and that transmit information to the spinal cord dorsal horn (or its trigeminal homologue - the nucleus caudalis). From there, the information continues to the brainstem and ultimately the cerebral cortex, where the perception of pain is generated. The pain is a product of higher brain center processing, whereas nociception can occur in the absence of pain.

Objective assessment of nociception poses a multitude of challenges. First, sedated or unconscious patients by definition cannot experience pain. Under these circumstances, it is more accurate to assess the nociception level. A body of research suggests that not managing nociception can lead to central changes in pain pathways that predispose individuals to chronic pain states.

Current "gold-standard" pain assessment tools rely on self-reporting, requiring an individual both to process external information and to communicate this personal experience.

Circumstances exist where self-reporting is not possible, or where it is unreliable. In these situations, surrogate markers utilize changes in behavioral or physiological parameters. However, their use can be associated with considerable shortcomings. They may be unreliable, hampered by observational bias, or influenced by disease processes or pharmacological interventions. Developing an objective method of pain assessment therefore needs to ensure tools that are sensitive and specific to pain. They need to be observer-independent, not reliant on the patient's ability to communicate and not influenced by disease characteristics.

A novel measure of nociception is the nociception level (NoL) index. It is based on objective measures related to changes in the autonomic nervous system. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate, heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude , skin conductance level, number of skin conductance fluctuations, and their time derivatives.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-100
  • Elective patient for laparoscopic cholecystectomy
  • Absence of acute or chronic pain

排除标准

  • Pregnancy
  • Dementia and mental retardation
  • Drugs that influence the autonomic system as beta blocker
  • Arrhythmia

结局指标

主要结局

pain level estimation by 1-100 scale by non invasive finger sensor

时间窗: up to 7 months

a finger sensor will estimate the pain by a numerical scale of 1-100 in which 1 stand for no pain and 100 stand for severe pain.

次要结局

未报告次要终点

研究者

发起方
Meir Hospital, Kfar Saba, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Elad

principal investigator

Meir Hospital, Kfar Saba, Israel

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