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临床试验/NCT05762159
NCT05762159已完成不适用

Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月10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
30
试验地点
1
主要终点
variation of the pupil size (in percentage)

研究概览

简要总结

Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.

This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.

详细描述

Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.

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 receiving erector spinae block for pain management of spinal osteosynthesis

排除标准

  • Patient refusal
  • Known allergy to local anesthetics
  • Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
  • Technical impossibility to perform a spinal erector block
  • Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
  • Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)
  • Serious psychiatric history
  • Drug abuse
  • Pregnancy

结局指标

主要结局

variation of the pupil size (in percentage)

时间窗: During the surgery

Evaluation the territory covered by the spinal erector block by variation of the pupil size (in percentage). Variation of the pupil size on stimulation will allow to deduce if the dermatome is covered by the spinal erector block analgesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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