Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- intensity of acute postoperative pain
研究概览
简要总结
Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.
详细描述
Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.
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, Outcomes Assessor)
盲法说明
PATIENT OUTCOME 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
- •over 18 years of age
- •ASA physical status I-III
- •elective partial mastectomy
排除标准
- •refusal of patient participation or inability to participate to the study
- •known allergic reaction to drugs included in the study design
- •contraindiations of performance of peripheral regional anesthesia
- •diabetes melitus or known neurological disorder
- •chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
- •all male patients
- •all patients not speaking the Greek language
结局指标
主要结局
intensity of acute postoperative pain
时间窗: 24 hours
intensity of acute postoperative pain, numeric rating scale 0-10
次要结局
- intensity of chronic pain(3 months)
- Prevalence of chronic neuropathic pain(3 months)
研究者
Chrysanthi Batistaki
Associate Professor of Anaesthesiology
Attikon Hospital