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临床试验/NCT06300606
NCT06300606招募中不适用

Is the Regional Anesthesia Technique Painful? an Evaluation Using the Nociception Index Level (NOL), a New Pain Monitoring, and Algiscore, a Multidimensional Pain Score

American Hospital of Paris1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
pain score

研究概览

简要总结

This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement.

详细描述

Introduction

Intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation. Recently, the Nociception Level index (NOL™) providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia. While this monitoring has also been used postoperatively in awake patients, data are scarce to assess pain under locoregional anesthesia. This study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb.

Method: 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included. Exclusion criteria were emergencies, request for general anesthesia, and patients under 18 years of age. All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice. After premedication with oral hydroxyzine, locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Monitoring began as soon as the venous infusion was started, and parameters were recorded at the time of locoregional anesthesia, tourniquet inflation, surgical incision, skin closure and dressing.

Pain is also assessed using the ALGISCORE by the nurse and the numerical scale (0 to 5) and satisfaction score at the end of the procedure. The need to administer midazolam or propofol at the anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). Data were analyzed using Friedman and Mann-Whitney tests.

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

  • scheduled upper limb orthopedic surgery under regional anesthesia

排除标准

  • Patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease

结局指标

主要结局

pain score

时间窗: intraoperative

ALGOPLUS pain scale

次要结局

  • sedative requirement(intraoperative)
  • anxiolytic requirement(intraoperative)
  • failure of regional anesthesia(intraoperative)

研究者

发起方
American Hospital of Paris
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilles BOCCARA

anesthesiologist, MD, PhD

American Hospital of Paris

研究点 (1)

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