LEVOBUPIVACAINE for Aortic valve disease

Inclusion criteria

• {"criterion_text":"- Adult patients (18 years of age or older)\n- Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy\n- Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV\n- Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%\n- Patient has given written, free and informed consent"}

Exclusion criteria

• {"criterion_text":"- BMI > 35\n- Patients who are unable to sufficiently speak and write in the Dutch language\n- Patients under legal protection (curatorship, guardianship)\n- Patients subject to a legal protection measure\n- An adult who is uncapable or unable to give consent\n- Patients requiring emergency surgery within 24 hours\n- Chronic opioid use (> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months)\n- Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, paracetamol, ondansetron\n- Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline)\n- Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery\n- Patients known with chronic pain\n- Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) < 30 ml.min-1.(1,73 m²)-1)\n- Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score ≥ 20)\n- Patients with pre-existing cognitive dysfunction (documented by geriatric or neurologic assessment)\n- Patients with uncontrolled epilepsy\n- Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) < 90 mmHg, cardiogenic shock)\n- Patients who simultaneously participate in another interventional clinical trial\n- Soft tissue infection in the area of the procedure\n- Patients who are pregnant, parturient or breast-feeding women"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Cumulative opioid consumption expressed in oral morphine milligram equivalents (OMEs) measured over the first 48 postoperative hours after completion of the surgical procedure."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Count of episodes with Numerical Rating Scale (NRS) score ≥ 4 at rest and at deep inspiration during the first 48 postoperative hours."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time from end of surgery to first administration of rescue analgesic (e.g. tramadol, oxycodone) within the first 48 postoperative hours."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Count of patients experiencing respiratory complications requiring NIV, HFNC, orotracheal intubation >24 hours, or re-intubation."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Arterial PaCO2 measured every 4 hours for up to 48 postoperative hours or until ICU discharge."}
• {"endpoint_text":"- Postsurgical recovery by QoR-15NL questionnaire on day before, first, second and seventh day after surgery","definition_or_measurement_approach":"Quality of recovery assessed using the QoR-15NL questionnaire preoperatively and on postoperative days 1, 2 and 7."}
• {"endpoint_text":"- Number of episodes of PONV in the first 48 postoperative hours","definition_or_measurement_approach":"Count of postoperative nausea and vomiting episodes during the first 48 postoperative hours."}
• {"endpoint_text":"- Time to extubation of the patient in the ICU","definition_or_measurement_approach":"Time from end of surgery to extubation in the ICU."}
• {"endpoint_text":"- Number of hours spent in the ICU (until ready for discharge)","definition_or_measurement_approach":"Total hours spent in ICU until patient is ready for discharge from ICU."}
• {"endpoint_text":"- Number of days in the hospital between surgery and first hospital discharge","definition_or_measurement_approach":"Number of days from surgery to first hospital discharge."}
• {"endpoint_text":"- The quality of life (QoL) by the EQ-5D questionnaire on the day before surgery and 30 days after surgery","definition_or_measurement_approach":"Quality of life measured using the EQ-5D questionnaire preoperatively and at 30 days post-surgery."}
• {"endpoint_text":"- Number of days alive and at home after surgery (DAH30)","definition_or_measurement_approach":"Days alive and at home within 30 days after surgery (DAH30)."}
• {"endpoint_text":"- Vital status at 30 days after surgery","definition_or_measurement_approach":"All-cause vital status assessed at 30 days post-surgery."}

Belgium

Earliest CTIS Part Ii Submission Date

03-06-2024

Latest Decision Or Authorization Date

12-08-2024

Processing Time Days

70

Number Of Sites

1

Number Of Participants

144

Primary sponsor

Full Name

Az Maria Middelares Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium