2023-509786-21-00招募中4 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 Gent1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年6月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs
研究概览
简要总结
To compare the analgesic effect of an interpectoral-pectoserratus plane (IPP-PSP) block in patients undergoing minimally invasive aortic valve replacement via right anterior minithoracotomy (AVR-RAT) with a control group (with sham block).
研究设计
- 分配方式
- Randomized
- 主要目的
- Trial design
- 盲法
- Double (Analyst, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
- •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
结局指标
主要结局
The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs
The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs
次要结局
- Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure
- Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure
- Number of patients with respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation
- Levels of PaCO2 measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until ICU discharge, whichever occurs first
- Postsurgical recovery by QoR-15NL questionnaire on day before, first, second and seventh day after surgery
- Number of episodes of PONV in the first 48 postoperative hours
- Time to extubation of the patient in the ICU
- Number of hours spent in the ICU (until ready for discharge)
- Number of days in the hospital between surgery and first hospital discharge
- The quality of life (QoL) by the EQ-5D questionnaire on the day before surgery and 30 days after surgery
- Number of days alive and at home after surgery (DAH30)
- Vital status at 30 days after surgery
研究者
Ella Hermie
Scientific
Az Maria Middelares Gent
研究点 (1)
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