Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative acute pain score at 6 hours
研究概览
简要总结
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.
详细描述
Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for an radical mastectomy and implant reconstruction surgery
- •Patients with American Society of Anesthesiologists (ASA) physical status I-II,
- •aged 18-70 years
排除标准
- •coagulation disorders,
- •known allergy to study drugs,
- •obesity (body mass index > 35 kg/m2),
- •infection at the injection site,
- •chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
- •patient refuse
研究组 & 干预措施
Control group
Control groups do not receive additional analgesia.
Erector spinae plane block group
Before surgery, an ultrasound-guided ESPB was performed. 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle.
Ropivacaine is produced by AstraZeneca AB under the trade name of Naropin, and the specifications are 75 mg / 10 ml. Dexmedetomidine is produced by HengRui medical China and the specifications are 100μg / 1 ml。
干预措施: Erector spinae plane block (Procedure)
结局指标
主要结局
Post-operative acute pain score at 6 hours
时间窗: 6 hours After surgery
11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery
次要结局
- Postoperative quality of recovery score(24 to 72 hours after the surgery)
- AUC of postoperative pain score(72 hours after the surgery)
- Post-operative acute pain score(1h, 12h,24, 48h, 72h after the surgery, separately.)
- Cumulative opioid consumption after surgery(48 hours after the surgery)
研究者
Jun Zhang
Director of the department of anaesthesiology, Shanghai cancer center
Fudan University