Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain evaluation
研究概览
简要总结
Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient who has given their free, informed and signed consent
- •Social security affiliation;
排除标准
- •pregnant woman
- •guardianship / curatorship / private patient under public law
- •surgery to be performed urgently (less than 24 hours)
- •surgery redux
- •thoracotomy surgery
- •sternotomy surgery
- •pleurectomy
- •patient participating simultaneously in another research that may interfere with results of the study
- •severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%).
- •Prior use of morphine;
- •chronic pain/chest neuropathies
- •patients with insulin-dependent diabetes and/or diabetic neuropathy.
- •severe kidney or liver failure.
结局指标
主要结局
Pain evaluation
时间窗: 48 hours after the surgery
Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10)
次要结局
- Post operative morphine dose Post operative administrated morphin dose(48 hours after the surgery)
- Morphine side effect quantification(48 hours after the surgery)
- Length of hospitalisation duration(1 year)
- Walking test(24 hours after the surgery)