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临床试验/NCT04147754
NCT04147754Unknown不适用

Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Pain assessment at H+48

研究概览

简要总结

Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.

Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.

These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these 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

  • Thoracic surgery for pulmonary resection
  • Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block

排除标准

  • No epidural anesthesia or no intrathecal morphine or no erector spinae block performed

结局指标

主要结局

Pain assessment at H+48

时间窗: Day 2 after surgery

Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)

次要结局

  • Length of stay in intensive care unit(Through study completion, an average of 1 year)
  • Total consumption of morphine (per and postoperative)(Hour 2, Day 1, Day 2 and Day 3 after surgery.)
  • Length of hospital stay(Through study completion, an average of 1 year)
  • Impact on respiratory function(Day 1, Day 2 and Day 3 after surgery.)
  • Frequency of adverse effects related to morphine Frequency of morphine side effects(Hour 2, Day 1, Day 2 and Day 3 after surgery.)
  • Postoperative pain assessment at other times(Hour 2, Day 1, and Day 3 after surgery.)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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