💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.
Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, includin
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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.
Exclusion Criteria:
* BMI \> 35;
* Patients under legal protection (curatorship, guardianship);
* Patients subject to a legal protection measure;
* An adult who is incapable 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 chronic pain;
* Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, acetaminophen, 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 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 preoperative cognitive dysfunction (Mini Mental State Examination (MMSE) score \< 24);
* 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;
* Patients who are unable to sufficiently speak and write in the Dutch language.
HealthTeky