Evaluation of the Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Preventing Post-thoracotomy Shoulder Pain in Thoracic Cancer Surgeries: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Percentage of patients with ipsilateral shoulder pain.
研究概览
简要总结
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.
详细描述
The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly.
Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient.
Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •American Society of Anesthesiologists (ASA) physical status class I and II.
- •Age ≥ 18 and ≤ 60 Years.
- •Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.
排除标准
- •Patient refusal.
- •Local infection at the puncture site.
- •Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
- •Unstable cardiovascular disease.
- •History of psychiatric and cognitive disorders.
- •Patients allergic to medication used.
结局指标
主要结局
Percentage of patients with ipsilateral shoulder pain.
时间窗: one hour postoperatively
Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.
次要结局
- Time to first rescue analgesia(24 hours postoperatively)
- Changes in postoperative heart rate(Preoperatively, intraoperatively, and 24 hours postoperatively)
- Changes in postoperative in mean arterial blood pressure(Preoperatively, intraoperatively, and 24 hours postoperatively.)
- Total intra-operative fentanyl consumption.(intraoperatively)
- Changes in postoperative oxygen saturation(24 hours postoperatively)
- Complications occurrence(24 hours postoperatively)
研究者
Muhammad Mahmoud Sami Salahaldin Megahed
Principal Investigator
Cairo University