NCT06312904已完成不适用
Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial
Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- opioid consumption during the first 24h after surgery
研究概览
简要总结
This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-14 years old;
- •Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;
- •Inform consent signed by the parent or legal guardian.
排除标准
- •Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;
- •Emergency surgery or redo cardiac surgery;
- •Body weight more than 50kg;
- •Diagnosed as severe pulmonary hypertension;
- •Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;
- •Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study;
- •Preoperative platelet counts less than 100*109/L, coagulopathy or bleeding tendency ;
- •Preoperatively using antiplatelets or anticoagulants;
- •Diagnosed with scoliosis or other contraindications for PVB.
结局指标
主要结局
opioid consumption during the first 24h after surgery
时间窗: 24 hours postoperatively
the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight
次要结局
- The rate of opioid treatment for remedial analgesia between groups(24 hours postoperatively)
- FPS-R scale recorded at 6, 12, 18 and 24h postoperatively(24 hours postoperatively)
研究者
Jingfei Guo
Attending Physician, Department of Anesthesiology
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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