Pain relief technique for heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the interpectoral-pectoserratus plane (IPP-PSP) block in reducing opioid consumption after minimally invasive aortic valve replacement surgery via right anterior minithoracotomy. Participants will be randomly assigned to receive either the IPP-PSP block or a placebo (sham block) to assess its impact on postoperative pain management. The primary endpoint is the total opioid consumption within the first 48 hours post-surgery, alongside secondary outcomes such as pain scores, recovery quality, and incidence of complications. The study aims to provide insights into the benefits of locoregional anesthesia in enhancing recovery after heart surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• AZ Maria Middelares
  Ghent, East-Flanders, Belgium Recruiting

Study contacts

• Principal investigator: Bart Vaes, MD — Algemeen Ziekenhuis Maria Middelares
• Study coordinator: Bart Vaes, MD
• Email: bart.vaes@mijnziekenhuis.be
• Phone: 0032 9 246 17 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.