CTIS2023-509786-21-00进行中（未招募）1 期
Interpectoral-pectoserratus plane block for minimally invasive aortic valve replacement via right anterior minithoracotomy: A single centre, prospective, double-blind, randomized controlled superiority trial
Az Maria Middelares Gent0 个研究点目标入组 144 人开始时间: 2024年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult patients (18 years of age or older), Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy, Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV, Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 = 4%, Patient has given written, free and informed consent
排除标准
- •BMI > 35, Patients who are unable to sufficiently speak and write in the Dutch language, Patients under legal protection (curatorship, guardianship), Patients subject to a legal protection measure, An adult who is uncapable or unable to give consent, Patients requiring emergency surgery within 24 hours, Chronic opioid use (> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months), Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, paracetamol, ondansetron, Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline), Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery, Patients known with chronic pain, Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) < 30 ml.min-1.(1,73 m²)-1), Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score = 20), Patients with pre-existing cognitive dysfunction (documented by geriatric or neurologic assessment), Patients with uncontrolled epilepsy, Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) < 90 mmHg, cardiogenic shock), Patients who simultaneously participate in another interventional clinical trial, Soft tissue infection in the area of the procedure, Patients who are pregnant, parturient or breast-feeding women
研究者
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