Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart beats
研究概览
简要总结
Sternum midline incision can offer better view under open-heart surgery and bigger operating space, and therefore it has been widely used in most cardiac surgery. If an event of urgency occurs, it takes on a more important role than infrasternal small incision. However, sternum midline incision may cause serious pain and aggravates stress response, and therefore patients are often reluctant to cooperate to cough which exerts adverse effect on postoperative rehabilitation, and even causes serious complications such as pulmonary inflammation, myocardial infarction and heart failure. Thus, the relief of pain and better perioperative analgesia are very important for these patients. Transversus thoracic muscle plane(TTMP) block and erector spinal muscle plane(ESP) block are used in open heart surgery currently, and they can provide good analgesia. This study aimed to investigate the hemodynamic stability, total amount of analgesic use, perioperative pain, stress response, postoperative complication and recovery in patients receiving TMP and ESP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 (18-75 years) with BMI at 18-25 kg/m2, ASA Ⅱ- Ⅲ and NYHA Ⅱ-Ⅲ who scheduled to undergo mitral valve or aortic valve replacement surgery.
排除标准
- •a second operation, preoperative ejection fraction (EF) < 40%, complicated coronary heart disease, intra-aortic balloon counterpulsation (IABP) support, psychiatric abnormalities, history of allergy to anesthetic drugs, liver or kidney dysfunction, coagulation abnormality, endocrine system diseases and metabolic diseases.
研究组 & 干预措施
General anesthesia only (G) group
Transversus thoracic muscle plane block (T) group
干预措施: Transversus thoracic muscle plane block or Erector spinal plane block (Procedure)
Erector spinal plane block (E) group
干预措施: Transversus thoracic muscle plane block or Erector spinal plane block (Procedure)
结局指标
主要结局
Heart beats
时间窗: steel wire pulling (T6)
the number of times each minute that heart beats
Mean arterial pressure
时间窗: steel wire pulling (T6)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: breast opening (T3)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: entering the operating room (T0)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: intubation (T1)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: skin incision (T2)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: sternal retractor placement (T4)
an average blood pressure in an individual during a single cardiac cycle
Mean arterial pressure
时间窗: pericardium incision (T5)
an average blood pressure in an individual during a single cardiac cycle
Heart beats
时间窗: entering the operating room (T0)
the number of times each minute that heart beats
Heart beats
时间窗: intubation (T1)
the number of times each minute that heart beats
Heart beats
时间窗: skin incision (T2)
the number of times each minute that heart beats
Heart beats
时间窗: breast opening (T3)
the number of times each minute that heart beats
Heart beats
时间窗: sternal retractor placement (T4)
the number of times each minute that heart beats
Heart beats
时间窗: pericardium incision (T5)
the number of times each minute that heart beats
次要结局
未报告次要终点
研究者
Le Yu
Clinicians
Shanghai East Hospital of Tongji University