Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative fentanyl consumption
研究概览
简要总结
This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.
详细描述
Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.
Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 60 years.
- •Both genders.
- •American Society of Anesthesiologists (ASA) physical status classification II or III.
- •Scheduled for thoracotomy.
排除标准
- •Poor cardiac function (ejection fraction less than 50%).
- •Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural.
- •Thoracic spine disorders require chest wall resection or emergency thoracic surgery.
- •Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).
研究组 & 干预措施
Thoracic epidural block group
Patients will preoperatively receive an awake thoracic epidural block.
干预措施: Thoracic epidural block (Other)
Paravertebral block group
Patients will preoperatively receive a paravertebral block.
干预措施: Paravertebral block (Other)
结局指标
主要结局
Intraoperative fentanyl consumption
时间窗: Intraoperatively
Additional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
次要结局
- Time to the 1st rescue analgesia(48 hours postoperatively)
- Mean arterial pressure(Till the end of surgery (Up to 2 hours))
- Heart rate(Till the end of surgery (Up to 2 hours))
- Total morphine consumption(48 hours postoperatively)
- Degree of pain(48 hours postoperatively)
- Degree of patient satisfaction(48 hours postoperatively)
- Incidence of adverse events(48 hours postoperatively)
研究者
Mohamed Elsaid Abdel Fattah
Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.
Cairo University