Pain Blocks in Awake Thoracic Surgery: A Randomized Prospective Trial to Test the Non-inferiority of Erector Spinae Plane Block (ESPB) in Comparison With Paravertebral Block During Non-intubate, Thoracoscopic Lung Resection.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Dose Escalation of systemic anesthetics during the procedure
研究概览
简要总结
A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection
详细描述
A prospective randomized trial which aims to evaluate a new technique of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing minimally invasive lung resection in spontaneous breathing, with intravenous sedation ("non-intubated thoracic surgery"). ESPB will be compared with a largely employed procedure for loco regional pain management: the Paravertebral block (PB). Both procedures are performed under ultrasonographic guidance to allow proper visualization of the target site. Surgery is carried out by means of a minimally invasive approach (Video Assisted thoracic Surgery) with two keyhole incisions on the affected side.
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
- Double (Participant, Care Provider)
盲法说明
Partecipant masking:
Both blocks are performed on the area between the scapula and the vertebral column, employing the same materials, so that the patient is masked about which block is going to be performed.
Care providers: once the block has been performed, a different anesthesiologist will take care of the patient during the procedure, eventually providing dose escalation in systemic analgesic drugs (primary end point). Surgeons performing the procedure are unaware of the type of block. Staff nurses managing post operative pain in terms of both recording (Numeric Rating Scale) and soothing (rescue analgesia distribution) are unaware of the type of block (secondary end points).
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
- •Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS approach.
- •Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in diameter.
- •Acceptance of awake VATS with written informed consent
排除标准
- •Age < 18 years
- •Patients who are pregnant or lactating
- •Morbid obesity (BMI > 35 )
- •Inability to understand and sign the Informed consent
- •Proven allergy to local anesthetic drugs as required by this protocol
- •Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection, redo surgery on the affected side)
结局指标
主要结局
Dose Escalation of systemic anesthetics during the procedure
时间窗: 1 hour from the end of the procedure
Percentage of patients who need sedation escalation
次要结局
- Post operative pain management(8, 16, 24 hours from the end of procedure)
- Post operative pain perception(8, 16, 24 hours from the end of procedure)