Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- time of the first rescue analgesic dose
研究概览
简要总结
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
详细描述
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
Inadequate pain management has both psychological and physiological repercussions.
Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.
Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications
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, Care Provider)
盲法说明
The patients and Care Provider in this trial were blinded
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
- •female patients
- •aged from 18 to 70 years
- •with a body mass index ≤ 30 kg/ m2
- •American Society of Anesthesiologists (ASA) physical status I-II,
- •who were scheduled for MRM for breast cancer
排除标准
- •history of drug allergy,
- •psychiatric illness, substance abuse,
- •severe cardiovascular or respiratory disease,
- •any pre-existing liver disease, metabolic or neurological syndrome, c
结局指标
主要结局
time of the first rescue analgesic dose
时间窗: 24 hours postoperatively
The time when the first dose of rescue analgesia was administered at the recovery room,
次要结局
- Heart rate changes(15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.)
- Mean arterial pressure changes(15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.)