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临床试验/NCT06731010
NCT06731010已完成不适用

Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Patients Undergoing Major Thoracic Surgery

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Postoperative pain

研究概览

简要总结

The primary aim of this study is to explore the relationship between alpha electroencephalographic oscillations, particularly Peak Alpha Frequency (PAF), pupillometry, intraoperative Nociception Level (NOL) and postoperative pain following major thoracic surgeries.

Goals to investigate the use of preoperative EEG as a biomarker for the prediction of postoperative pain to investigate the use of pupillometry in postoperative pain prediction and evaluation to test intraoperative NOL as a predicting factor of postoperative pain

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer.

排除标准

  • Severe neurological disorders (e.g. dementia) that could interfere with EEG recordings or pain testing.
  • Severe psychiatric conditions such as major depression, schizophrenia, or active drug abuse.
  • Preoperative analgesic therapy, which may alter EEG signals (Boord et al. 2008).
  • Diabetes mellitus 5) Chronic pain of any etiology 6) Acute pain from any cause

结局指标

主要结局

Postoperative pain

时间窗: Pain intensity was recorded immediately postoperatively in the Post-Anesthesia Care Unit (PACU), as well as at 24, 48, and 72 hours after the surgery. Chronic postoperative pain was assessed both one month and three months after surgery.

Pain intensity in patients was assessed postoperatively using the Numeric Rating Scale (NRS), specifically the Eleven-point NRS (NRS 0-10). Responses were categorized as follows: 0 : no pain, scores from 1 to 3 indicated mild pain, a score of 4-6 represented moderate pain, and scores of 7 or higher signified severe pain.Patients' postoperative late pain was assessed using NRS and the DN4 index. The DN4 (Douleur Neuropathique 4 questions) is a validated questionnaire used to diagnose neuropathic pain. It is utilized to evaluate postoperative pain and assess symptoms related to neuropathic pain, such as the spread of pain and alterations in sensory perception

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chrysanthi Barba

Anaesthesiology Resident GH Evangelismos

National and Kapodistrian University of Athens

研究点 (2)

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