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Interpectoral-pectoserratus plane block for minimally invasive aortic valve replacement via right anterior minithoracotomy
EU CTIS ID: 2023-509786-21-00
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.