Comparison of Programmed Intermittent Bolus Infusions of Spinae Plane Block Versus Paravertebral Block for Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- pain at cough after surgery
研究概览
简要总结
Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.
详细描述
Minimally invasive direct coronary artery bypass grafting has recently gained with popularity in treatment of coronary artery disease. Compared with conventional approach, it has advantages of less trauma and rapid recovery, but postoperative pain is severe, which may increase the risk of cardiopulmonary complications and cause chronic pain. Therefore, perioperative analgesia is crucial in minimally invasive direct coronary artery bypass grafting.
Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective minimally invasive direct coronary artery bypass grafting
排除标准
- •Contraindications to regional anesthesia (coagulopathy, infection of the skin at the site of needle puncture area, et al)
- •Morbid obesity (body mass index > 35 kg/m2)
- •Allergy to any of the study drugs
- •Chronic opioid use or history of opioid abuse.
- •Inability to understand pain score
研究组 & 干预措施
thoracic paravertebral block
A needle is inserted into the paravertebral space. After confirming the needle tip position, 20 ml of 0.5% ropivacaine is injected in the paravertebral space. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery.
干预措施: Ropivacaine (Drug)
erector spinae plane block
A needle is inserted until the tip contacted the T5 transverse process under ultrasound guidance. After confirming the needle tip position, 20 ml of 0.5% ropivacaine was injected in the plane between the erector spinae muscles and transverse process. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery
干预措施: Ropivacaine (Drug)
结局指标
主要结局
pain at cough after surgery
时间窗: postoperatively 0-3 day
Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)
postoperative rescue analgesic consumption
时间窗: postoperatively 0-3 day
morphine equivalents
次要结局
- dermatome of block(immediately after extubation)
- pain at rest after surgery(postoperatively 0-3 day)
- adverse events of regional block(Intraoperative (during and immediately after block performance))
研究者
Min Li
Vice Director of the Department of Anesthesiology, Principal Investigator, Clinical Professor
Peking University Third Hospital