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临床试验/NCT04025606
NCT04025606已完成不适用

Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年6月24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
发起方
入组人数
94
试验地点
1
主要终点
Time in minutes total time at the operating ward

研究概览

简要总结

Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy
  • Exclusion Criteria, preoperative:
  • Patients who do not wish to participate
  • Patients with:
  • suspicion of ingrowth in the thoracic wall.
  • marginal lung function.
  • kidney failure.
  • chronic pains and/ or daily use of opioids.
  • cognitive, visual and / or linguistic dysfunction.
  • allergies to drugs used in the paravertebral block or the thoracic epidural analgesia.
  • Exclusion Criteria, Per- and postoperative
  • conversion from VATS to thoractomy.
  • unsuccessful admission of thoracic epidural analgesia
  • unsuccessful admission of paravertebral block
  • postoperative respiratory treatment
  • postoperative delirium Patients who for various reasons are not able to self-report pain after surgery.
  • Patients who wish to withdraw from the study

排除标准

  • 未提供

研究组 & 干预措施

Thoracic epidural analgesia

Active Comparator

Standard thoracic epidurals preoperatively at the dag of surgery.

干预措施: Thoracic epidural (Drug)

Paravertebral block

Experimental

Paravertebral block inserted at the end of the operation by the surgeons

干预措施: Paravertebral block (Drug)

结局指标

主要结局

Time in minutes total time at the operating ward

时间窗: 1 hour

Pain intensity during hospitalization: Numerical Rating Scale (NRS)

时间窗: Up to 12 months after surgery

using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation

次要结局

  • Hospital length of stay in days(until discharge from hospital (max 1 month))

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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