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临床试验/NCT05294315
NCT05294315Unknown不适用

The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Opioid use in first 12 postoperaive hour

研究概览

简要总结

Video assisted thoracoscopic surgery (VATS) is a minimally invasive surgery to remove lesions from the thoracic cavity. It is associated with moderate pain which can lead to pulmonary complications after surgery. The Enhanced Recovery After Surgery (ERAS) and the European Society of Thoracic Surgeons recommended a multimodal analgesia approach to manage pain after VATS. Erector spinae block (ESB) is a popular analgesic block due to its ease of performance and wide coverage. It has been shown to be effective in randomized control trials. Recently, case reports on bi-level ESB are emerging, suggesting more effective analgesia compared to single level ESB. As there is no available data, the investigators are interested in conducting a randomized pilot study, comparing bi-level to single level ESB to gather baseline data for sample size calculation for a formal randomized trial.

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 (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

  • adult patients (at least 18 years old)
  • elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS

排除标准

  • history of malignant hyperthermia
  • BMI > 40, chronic pain condition
  • Daily opioid consumption of more than 60 mg oral morphine equivalents
  • Conversion to thoracotomy
  • Insertion of epidural
  • postoperative admission to ICU

结局指标

主要结局

Opioid use in first 12 postoperaive hour

时间窗: First 12 hour from arriving at postoperative recovery

次要结局

  • Incidence of Delayed block complication - based on clinical assessment(First 5 days)
  • Pain score area under curve first 12 hour(First 12 hour from arriving at postoperative recovery)
  • Incidence of Acute block complication - based on clinical assessment(First 12 hour since block placement)
  • Pain score area under curve first 24 hour(First 24 hour from arriving at postoperative recovery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng Lin

Clinical Professor

Lawson Health Research Institute

研究点 (2)

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