A Prospective, Randomized Comparison Between Paravertebral and Pectoral Nerve Block on Postoperative Pain, Persistent Post Surgical Pain and Cancer Recurrence After Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Morphine requirement
研究概览
简要总结
Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.
Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.
详细描述
Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.
All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining.
Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered.
Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h.
Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for radical mastectomy for cancer.
- •age > 18 y-o
- •Written informed consent
排除标准
- •Bilateral surgery
- •Opioids user
- •BMI > 35
- •Postoperative Intensive care
研究组 & 干预措施
pectoral PECS II block
Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml
干预措施: PECSII and paravertebral blocks (Procedure)
Paravertebral nerve block
Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)
干预措施: PECSII and paravertebral blocks (Procedure)
结局指标
主要结局
Morphine requirement
时间窗: 1 day
Morphine self-administered by a patient controlled device
次要结局
- Persistent Postsurgical pain (PPSP)(2 years)
- cancer recurrence(2 years)
- postoperative pain(2 days)