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临床试验/NCT04538235
NCT04538235已完成不适用

Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年10月20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
90
试验地点
1
主要终点
cumulative morphine consumption on postoperative day 2

研究概览

简要总结

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.

The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.

Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • To be over
  • To be scheduled for VATS in the center of the study during the study period.
  • Thoracic Epidural analgesia of Bi-block analgesia.

排除标准

  • Chronic pain or opioid use before surgery (6 months).
  • Postoperative hospitalization in ICU during the first two days.
  • Postoperative surgical complication needing surgical revision during the first two days.
  • Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.

结局指标

主要结局

cumulative morphine consumption on postoperative day 2

时间窗: postoperative day 2

cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.

次要结局

  • non-opioid analgesics consumption on postoperative day 2(postoperative day 2)
  • Pain assessed by visual analog pain scale (VAS)(up to postoperative day 2)
  • Urinary retention(up to postoperative day 2)
  • hypotension(up to postoperative day 2)
  • pleural drain duration(up to postoperative day 2)
  • duration of hospitalization(up to postoperative day 2)
  • occurrence of prurit(up to postoperative day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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