Observational Study of an Automatic Detection of Patients at Risk of Chronic Postoperative Pain ("Alerte Douleur") (ALDO)
Étude Observationnelle Prospective d'Une Alerte Douleur informatisée Automatique Par Les Applications Informatiques hospitalières Des HUG Pour prédire l'Apparition de Douleurs Chroniques Post opératoires
Following surgery, some but not all patients develop persistent (or chronic) postoperative pain CPSP. Several risk factors for this persistent pain have been confirmed in previous studies, but neither surgeons nor anesthesiologists have or take the time to systematically screen patients for this risk. However, hospital information systems often contain the data already, entered during preoperative consultations (e.g. chronic opioid medication) or obtained during the postoperative period (e.g. pain scores).
Here the investigators test an automatic detection algorithm which alerts the analgesia team when a patient at risk of CPSP is or has been operated.
研究概览
详细说明
The primary aim of the study is to confirm that the sensitivity of the automatic alert is at least 80%, i.e. that 80% of patients with the primary outcome had an automatic alert.
The secondary aim of the study is to develop an algorithm (combination of risk factors) with which the specificity of the alert can be improved.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Genève、瑞士
- Hôpitaux Universitaires de Genève
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 years of age
- elective surgery
- perioperative use of the hospital information system
- surgery of the following types: endoprosthesis of the knee or shoulder, amputation other than toe or finger, spinal surgery, cardio-thoracic thoracotomy, laparotomy, inguinal hernia repair, breast surgery
Exclusion Criteria:
- inability to read and understand the consent form or the questionnaires
- emergency surgery
- having already participated in the study for another surgery
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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CPSP at 6 months
大体时间：6 months
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mean pain intensity in the "brief pain inventory" of at least 3/10
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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CPSP at 12 months
大体时间：12 months
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mean pain intensity in the "brief pain inventory" of at least 3/10
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12 months
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clinically significant pain at 6/12 months
大体时间：6/12 months
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either a pain intensity of >=3 at rest or >=5 on movement or use of analgesics
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6/12 months
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neuropathic pain at 6/12 months
大体时间：6/12 months
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mean pain intensity in the "brief pain inventory" of at least 3/10 AND a DN4 score of at least 4
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6/12 months
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acute postoperative pain
大体时间：24h postoperative
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mean pain score and highest pain score in the first 24h postoperative on a 0-10 verbal numeric rating scale
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24h postoperative
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pain-related functional deficit at 6/12 months
大体时间：6/12 months
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pain interference scales of the brief pain inventory, number of days not working
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6/12 months
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persistent opioid use
大体时间：6/12 months
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patient reported use of tramadol (yes/no) or use of strong opioids (yes/no)
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6/12 months
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合作者和调查者
调查人员
- 首席研究员：Ali Bourezg, MD、Hôpitaux Universitaires de Genève
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
automatic risk detection的临床试验
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University of OuluOulu University Hospital完全的