跳至主要内容
临床试验/NCT04579276
NCT04579276已完成不适用

Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
total morphine consumption

研究概览

简要总结

Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).

详细描述

A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).

Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • Male or female ≥ 18 years of age.
  • VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
  • Signed consent.
  • Scheduled surgeries.

排除标准

  • Patient refusing to sign the consent form.
  • Patients under any guardianship.
  • All surgeries with pleura intervention: talc, pleurectomy, wall resection.
  • Non trained anesthesiologist to ultrasound TPB.
  • Presence of pain or daily use of painkillers prior to surgery.
  • Medical history of homolateral thoracic surgery.

研究组 & 干预措施

"surgical" method

Experimental

干预措施: Thoracic paravertebral block (Procedure)

"anesthetic" method

Active Comparator

干预措施: thoracic epidural analgesia (Procedure)

结局指标

主要结局

total morphine consumption

时间窗: 48 HOURS

次要结局

  • visual analog scale of pain (VAS)(30 DAYS)
  • Time occupancy of the operating room(1 MONTH)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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