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临床试验/NCT04912557
NCT04912557Unknown不适用

Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Insufficient epidural analgesia

研究概览

简要总结

Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

详细描述

Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.

In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.

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

  • Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
  • epidural analgesia accepted

排除标准

  • Minor or protected patient
  • Patients under guardianship, curatorship or safeguard of justice
  • Pregnant or breastfeeding woman
  • Contraindication or refusal of epidural analgesia
  • Failure of the initial placement of the epidural catheter
  • Major intraoperative complication requiring continued postoperative sedation

结局指标

主要结局

Insufficient epidural analgesia

时间窗: day 5

Insufficient epidural analgesia will be defined by the presence of pain assessed by numerical scale \> 3/10 at rest OR on coughing OR on mobilization.

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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