Management Protocol for Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- QoR Score at Day 1
研究概览
简要总结
This study aims to compare two loco-regional analgesic techniques:
- Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.
- Ultrasound-guided ESPB: Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
This protocol is intended for patients undergoing video-assisted thoracoscopic surgery (VATS) for pneumonectomies, lobectomies, wedge resections, and bullectomies.
Primary Endpoint:QoR Score at 24 hours (validated questionnaires. Secondary Endpoints: Intraoperative NOL, QoR at 48-72 hours, opioid consumption at 12-24-48 hours, NLR at 24 hours, CPSP incidence at 3 months.
详细描述
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure that offers numerous advantages over traditional thoracotomy, including reduced surgical stress, lower postoperative pain, improved postoperative pulmonary function, reduced mortality, and shorter hospital stays.
Although VATS is less painful than open surgery, patients may still experience significant postoperative pain. Therefore, effective pain management is crucial to reducing postoperative complications and preventing acute postoperative pain from progressing to chronic pain.
Thoracic epidural analgesia and thoracic paravertebral blocks provide adequate pain control for thoracic surgery but may be associated with complications that can prolong hospital stays and increase morbidity.
Thus, recent trends favor less invasive regional analgesic techniques combined with systemic analgesia. Systemic analgesia follows a multimodal approach, incorporating intravenous medications such as acetaminophen, NSAIDs, lidocaine, and α2-adrenergic agonists.
Recent PROSPECT (PROcedure SPECific Postoperative Pain ManagemenT) guidelines recommend the erector spinae plane block (ESP) or paravertebral block (PVB) for postoperative analgesia following VATS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Signed informed consent
- •Elective unilateral surgery
排除标准
- •Minor patients
- •BMI > 40
- •Unstable neurological disorders
- •Known allergy to acetaminophen and NSAIDs
- •Chronic renal failure (stage > 4, whith GFR between 29 and 15 mL/min)
- •Patient refusal
- •Chronic use of NSAIDs and opioids in the 3 months prior to surgery
- •Contraindications to peripheral block (infection al the insertion site, allergy to local anesthetics, severe coagulation disorders)
结局指标
主要结局
QoR Score at Day 1
时间窗: From end surgery to Day 1 after surgery
次要结局
- Intraoperative NOL (Nociception Level Index®)(From start to end surgery)
研究者
Luca Guzzetti
MD
Ospedale di Circolo - Fondazione Macchi