Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Post-extubation 1st hour measurement
研究概览
简要总结
Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to investigate the optimal local anesthetic volume (20 mL versus 30 mL) with ESP block for open-heart cardiac surgery.
详细描述
In cardiac surgery, the most common cause of pain during the first two days postoperatively is median sternotomy. In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively, postoperative 24 hours pain scores ranging from 5.3 to 6.5 out of 10 with deep breathing and coughing were shown. In these patients, it may increase the frequency of atelectasis due to reasons such as failure in pain control, weak coughing, and limitation of movement, and these may lead increase in morbidity and hospital stay. Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain, they are far from being ideal analgesics alone due to their side effects such as kidney damage, bleeding risk, sedation, respiratory depression, itching, nausea, and vomiting. The complications of neuraxial techniques seem to be the disadvantages of these methods. Erector spinae plane (ESP) block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries.
The Erector spinae plane (ESP) block was first described by Forero in 2016. In this block technique, a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process. The dorsal and ventral branches of the spinal nerves are blocked in this plane. However, due to individual regional anatomical differences, there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur. Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue.
This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy
排除标准
- •Emergency surgeries
- •Patients with allergic reactions to anesthesia and analgesia drugs to be used
- •Patients who do not want to participate in the study voluntarily
- •Severe systemic disease (kidney, liver, pulmonary, endocrine)
- •Substance abuse history
- •History of chronic pain
- •Psychiatric problems and communication difficulties
- •Patients who need revision due to hemostasis in the postoperative period
- •Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.
结局指标
主要结局
Post-extubation 1st hour measurement
时间窗: 1 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 8th hour measurement
时间窗: 8 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 2nd hour measurement
时间窗: 2 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 12th hour measurement
时间窗: 12 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 24th hour measurement
时间窗: 24 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 4th hour measurement
时间窗: 4 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
次要结局
- Mechanical ventilation duration(postoperative, approximately 4 to 10 hours)
- intensive care unit duration(postoperative, approximately 12 to 36 hours)
研究者
Eda Balci
Principal investigator
Ankara City Hospital Bilkent