Pain relief technique for heart surgery

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy: a Single Centre, Prospective, Double-blind, Randomized Controlled Superiority Trial

This study is testing a new pain relief technique to see if it can help people use less opioid medication after heart surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Algemeen Ziekenhuis Maria Middelares (Academic / other)
• Locations: 1 site (Ghent, East-Flanders)
• Trial ID: NCT06369870 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for minimally invasive aortic valve replacement surgery.

Not a fit: Patients with chronic opioid use or those requiring emergency surgery within 24 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce opioid use and improve pain management for patients undergoing heart surgery.

How similar studies have performed: Other studies have shown promising results with similar locoregional anesthesia techniques, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Ghent, East-Flanders

• AZ Maria Middelares — Ghent, East-Flanders, Belgium (Recruiting)

Study contacts

• Principal investigator: Bart Vaes, MD — Algemeen Ziekenhuis Maria Middelares
• Study coordinator: Bart Vaes, MD

Conditions Analgesic Effect; interpectoral-pectoserratus plane block; aortic valve replacement via right anterior minithoracotomy; IPP-PSP block; AVR-RAT