Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Intraoperative Fentanyl consumption
研究概览
简要总结
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.
PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.
ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.
Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.
Study type: RCT, single blind.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery.
Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mastectomy program with axillary clearence
排除标准
- •bilateral surgery
结局指标
主要结局
Intraoperative Fentanyl consumption
时间窗: Intraoperative
Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.
次要结局
- Nausea and vomit incidence(postoperative period (24h))
- Time to first opioid consumption in the postoperative period(postoperative period (24h))
- NRS at 12 hour(twelth postoperative hour)
- NRS at 24 hour(twentyfourth postoperative hour)
- NRS at 6 hour(sixth postoperative hour)
- Patient satisfaction at 24 hour(postoperative period (24h))
- Postoperative morphine consumption(postoperative period (24h))
- Other complication incidence(postoperative period (24h))
- Intraoperative Fentanyl consumption(mcg/kg/h)(Intraoperative)
研究者
Alessandro De Cassai
Principal Investigator
University of Padova