The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total dose of fentanyl consumption during the postoperative 24h
研究概览
简要总结
Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate the efficacy of intraoperative PECS block for postoperative analgesia after robot breast surgery and immediate breast reconstruction.
详细描述
Sixty patients were randomly allocated into two groups by computerised process, each including 30 patients. PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator. Control group(C) only received general anesthesia.
A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.
The Primary outcome measures total dose of fentanyl consumption during the postoperative 24 hours, and secondary outcome measures pain scores at rest and movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20years or older
- •Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
- •American Society of Anesthesiologists(ASA) physical status I and III
排除标准
- •Emergency operation
- •Reoperation
- •Patients with local anesthetic allergy
- •Patients with coagulopathy
- •Patients on anticoagulants
- •Patients who cannot use patient controlled analgesia(PCA)
- •Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
- •Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
- •Patients with history of heart failure (unstable angina, congestive heart failure)
- •Patients with history of liver failure, renal failure, allergic to medicine
- •Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
- •Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
- •Patients who cannot read the consent form (examples: Illiterate, foreigner)
- •Patients who withdraw the consent
结局指标
主要结局
Total dose of fentanyl consumption during the postoperative 24h
时间窗: after 24 hours postoperative period
To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h
次要结局
- a numeric rating score at rest(24 hours after surgery)
- a numeric rating score at movement(24 hours after surgery)