Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Quality of recovery after anesthesia (QoR15) questionnaire
研究概览
简要总结
For many patients, a primary source of postoperative pain following cardiac surgery is the presence of pleural drains, which the surgeon places at the end of the operation and maintains for 1 to 3 days. One promising method of pain management after cardiac surgery is interpleural analgesia, particularly when traditional analgesic methods, such as systemic opioids or epidural anesthesia, may be limited due to the risk of complications. Interpleural analgesia involves the introduction of local anesthetics directly into the pleural cavity through drainage tubes placed after cardiac surgery. This method targets pain receptors in the chest area, providing effective analgesia without significant systemic effects. Several clinical studies have confirmed the safety and efficacy of intrapleural administration of anesthetics after thoracic surgery. The aim of this randomised double-blind placebo controlled study is to test the hypothesis that, in patients after cardiac surgery, the quality of recovery from anesthesia with intrapleural use of ropivacaine is superior to that with a placebo.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled cardiac surgery using a standard median sternotomy.
- •Planned opening of the pleural cavities.
- •Age more than 18 years.
- •Signed informed consent to participate in the study.
排除标准
- •Contraindications for ropivacaine
- •Redo surgery
研究组 & 干预措施
Intrapleural ropivacaine
干预措施: Ropivacaine (Drug)
Intrapleural placebo
干预措施: 0.9 % NaCl (Drug)
结局指标
主要结局
Quality of recovery after anesthesia (QoR15) questionnaire
时间窗: 24 hours after surgery
ranged from 0 to 150 points, where 0 is the worst and 150 is the best.
次要结局
- pO2/FiO2 ratio(6, 12, 24 hours after surgery)
- Morphine equvalents, mg/day(24 hours after surgery)
- Pain assessed by Visual analog scale(6, 12, 24, 48 hours)
研究者
Efremov Sergey
Deputy director for science, Saint-Petersburg state university hospital
Saint Petersburg State University, Russia
