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临床试验/NCT07116343
NCT07116343招募中4 期

Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study

Saint Petersburg State University, Russia2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年10月22日最近更新:
适应症
干预措施
相关药物

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

Experimental

干预措施: Ropivacaine (Drug)

Intrapleural placebo

Placebo Comparator

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

发起方
Saint Petersburg State University, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Efremov Sergey

Deputy director for science, Saint-Petersburg state university hospital

Saint Petersburg State University, Russia

研究点 (2)

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