Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- D0 pain intensity
研究概览
简要总结
The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.
详细描述
In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.
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
The patient where randomized by the investigator after inform consent was signed The investigator prepared the syringes named "serratus" and "local" with levobupivacaine 0.25 or saline according to randomization The care provider injected the prepared syringes respectively in the serratus plane or locally without knowing their contents The outcome assessor evaluated the post operative pain and the 3 months followup without knowing the randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery
排除标准
- •non robot-assisted surgery
研究组 & 干预措施
serratus
Serratus plane block and local control
干预措施: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline (Drug)
serratus
Serratus plane block and local control
干预措施: 0.5% levobupivacaine injectable solution with physiological saline (Drug)
local
serratus control and local anesthesia
干预措施: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline (Drug)
local
serratus control and local anesthesia
干预措施: 0.5% levobupivacaine injectable solution with physiological saline (Drug)
结局指标
主要结局
D0 pain intensity
时间窗: 1 day
Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)
次要结局
- morphine consumption(5 days)
- D1 pain intensity(3 days)
- persistence of a chronic pain(3 months)