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临床试验/NCT03164954
NCT03164954终止不适用

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

Benno Rehberg-Klug1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
355
试验地点
1
主要终点
CPSP at 6 months

研究概览

简要总结

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.

详细描述

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

  • 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

排除标准

  • inability to read and understand the consent form or the questionnaires
  • emergency surgery
  • having already participated in the study for another surgery

结局指标

主要结局

CPSP at 6 months

时间窗: 6 months

mean pain intensity in the "brief pain inventory" of at least 3/10

次要结局

  • clinically significant pain at 6/12 months(6/12 months)
  • acute postoperative pain(24h postoperative)
  • CPSP at 12 months(12 months)
  • neuropathic pain at 6/12 months(6/12 months)
  • pain-related functional deficit at 6/12 months(6/12 months)
  • persistent opioid use(6/12 months)

研究者

发起方
Benno Rehberg-Klug
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Benno Rehberg-Klug

médecin adjoint agrégé

University Hospital, Geneva

研究点 (1)

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