Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- postoperative chronic pain
研究概览
简要总结
Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.
详细描述
The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performing median sternotomy
- •Elective case
- •Over 18 years of age; under 80 years of age
- •ASA II-III patients
排除标准
- •Emergency cases
- •Patients undergoing minimally invasive surgery
- •Patients with a history of opioid use in the last 30 days
- •Redo cases
- •Patients with left ventricular ejection fraction less than 30%
- •Patients with severe hepatic or renal insufficiency
- •Patients with chronic pain before surgery (migraine, fibromyalgia)
结局指标
主要结局
postoperative chronic pain
时间窗: 6 months
Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.
次要结局
- icu time(7 days)
- postoperative 24 hours acute pain(24 hours)
- extubation time(24 hours)
研究者
münire deniz
Principal Investigator Medical Doctor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital