Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- severity of early postoperative pain
研究概览
简要总结
The main aim of this study is to compare the effectiveness of three alternative techniques (continuous Erectus Spinae Plane Block : c-ESPB; continuous Serratus Anterior Plane Block : c-SAPB; and Intercostal Nerve Block: ICNB) in reducing the severity of early postoperative pain after Uniportal-VATS lung resections. Primary outcomes will be opioid and other analgesic drugs consumption in the 72 hours after surgery, and static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively. Further outcomes will be incidence of pulmonary and cardiac complications until patient's discharging, pain when removing drains, presence/absence of chronic neuropathic pain (12 weeks after surgery).
详细描述
Patients will be enrolled into three groups:
- continuous Erector Spinae Plane Block group (c-ESPB group)
- continuous Serratus Anterior Plane Block group (c-SAPB group)
- Intercostal Nerve Block group (ICNB group)
- In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
- In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately after chest wall disclosure, by injection of 20 ml 0,2% ropivacaine into the fascial plane deep to the Serratus Anterior muscle. After the initial bolus, a catheter will be left into the fascial plane deep to the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
- In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately after drain placement, by injection of 20 ml of 0,2% ropivacaine from within the chest under direct visualization of the intercostal spaces. The "one-shot" ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump.
The enrollment of patients into a specific group will depend on surgical variables (like disruption or not of serratus muscle/intercostal fascial planes), availability of an operator (surgeon/anesthesiologist) skilled in performing peripheral nerve blocks, logistic variables (availability of materials and ultrasound equipment).
The above mentioned primary/secondary outcome measures will be evaluated in each group and compared among them.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
排除标准
- •Patients who will not sign the informed consent.
- •Patients scheduled for open thoracic surgery or not undergoing Uniportal-VATS resections.
- •Patients undergoing concomitant chest wall, diaphragm resection or mechanical/chemical pleurodesis.
- •History of previous thoracic surgery.
- •Patients with Chronic Post-Thoracotomy Pain.
- •Rib cage deformity or scoliosis.
- •Inherited or acquired coagulopathies.
- •History of allergy to drugs used during the study.
- •Age < 18 years.
- •Patients suffering from psychiatric or neurodegenerative diseases.
结局指标
主要结局
severity of early postoperative pain
时间窗: first 48 hours after extubation
static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively.
analgesic drug consumption
时间窗: first 72 hours after extubation
number of doses of analgesic drugs administered on patients' request during the postoperative period
次要结局
- pain at drain removal(chest drain removal (third/fourth postoperative day))
- respiratory and cardiac complications(first 72 hours after extubation)
- incidence of chronic pain(12 weeks after surgery)