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临床试验/EUCTR2020-004178-23-FI
EUCTR2020-004178-23-FI进行中(未招募)1 期

ltrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block (TTP) via catheter and postoperative pain in Cardiac Surgery - TTPcat

Turku University Hospital0 个研究点目标入组 120 人开始时间: 2021年2月10日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.18 - 80 years of age
  • 2.Scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
  • 3.Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
  • 4.Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
  • 5.Written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 120
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.A previous history of intolerance to the study drug or related compounds and additives
  • 2.Redo surgery
  • 3.Combined CABG and heart valve surgery
  • 4.Endocarditis and/or mediastinitis
  • 5.Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
  • 6.Patients younger than 20 years or older than 80 years.
  • 7.Body weight < 60 kg
  • 8.BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
  • 9.Existing significant liver or kidney disease
  • 10.History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
  • 11.Cardiac insufficiency, ejection fraction (LVEF) < 30 %
  • 12.Patients with a diagnosis for neuropathic pain or chronic pain syndrome
  • 13.Insulin dependent diabetes mellitus with neuropathy
  • 14.Participating in other clinical trial under TTP study
  • 15.Donation of blood for 4 weeks prior and during the study

研究者

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