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Study on Pain Relief Using Levobupivacaine, Sodium Chloride, and Piritramide for Patients Undergoing Minimally Invasive Aortic Valve Replacement

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a specific pain management technique for patients undergoing a type of heart surgery known as minimally invasive aortic valve replacement. This surgery is performed through a small incision in the chest, called a right anterior minithoracotomy. The trial aims to compare the pain relief provided by a method called the interpectoral-pectoserratus plane block with a control group that receives a sham block. The main goal is to see how well this pain management technique works in reducing the need for pain medication after surgery.

The study involves the use of three different medications. The first is Levobupivacaine, which is a local anesthetic used to numb the area and reduce pain. The second is Sodium Chloride, commonly known as salt water, which is used as a standard solution for infusion. The third is Piritramide, a pain-relieving medication that is administered intravenously. These medications are used to help manage pain and improve recovery after the surgery.

Participants in the study will be randomly assigned to receive either the interpectoral-pectoserratus plane block or a sham block. The trial will monitor various aspects of recovery, including the amount of pain medication needed, the level of pain experienced, and any complications that may arise. The study will also assess the overall quality of life and recovery process for patients after surgery. The trial is expected to continue until the end of 2027, with recruitment starting in March 2024.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, scheduled surgery, and health status.

    Written, informed consent is required to participate.

  2. Step 2

    Pre-surgery preparation

    Before surgery, a questionnaire assessing quality of recovery is completed.

    Preparation for the minimally invasive aortic valve replacement surgery is conducted.

  3. Step 3

    Surgical procedure

    The surgery involves a minimally invasive aortic valve replacement via right anterior minithoracotomy.

    An interpectoral-pectoserratus plane block may be administered to manage pain, or a sham block for control purposes.

  4. Step 4

    Postoperative care

    Post-surgery, pain management is monitored, focusing on opioid consumption within the first 48 hours.

    Pain levels are assessed using a numerical rating scale, and additional pain relief may be provided if necessary.

  5. Step 5

    Monitoring and recovery

    Respiratory function is monitored, and interventions like non-invasive ventilation may be used if needed.

    Carbon dioxide levels in the blood are checked every 4 hours during the first 48 hours post-surgery.

  6. Step 6

    Quality of recovery assessment

    Recovery is evaluated using a questionnaire on the first, second, and seventh day after surgery.

    The quality of life is assessed before surgery and 30 days after surgery.

  7. Step 7

    Hospital discharge

    The time spent in the intensive care unit and the hospital is recorded.

    The number of days alive and at home after surgery is tracked.

  8. Step 8

    Follow-up

    Vital status is checked 30 days after surgery to ensure ongoing recovery.

Who can join the trial?

5 criteria

  • Adult patients who are **18 years of age or older**.
  • Patients who are scheduled for a **minimally invasive aortic valve replacement** through a small incision on the right side of the chest.
  • Patients with an **American Society of Anesthesiologists (ASA) physical status classification** of II, III, or IV. This is a system used to assess the fitness of patients before surgery, with II being mild disease, III being severe disease, and IV being very severe disease.
  • Patients with a **European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2** of 4% or less. This is a score used to predict the risk of death after heart surgery, with lower scores indicating lower risk.
  • Patients who have given their **written, free, and informed consent** to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have **aortic valve disease** cannot participate. This means the study is only for those with a problem in the heart valve that controls blood flow from the heart to the body.
  • Patients who are not in the age range of 18 to 64 years old cannot participate. This means the study is only for adults in this age group.
  • Patients who are not undergoing a specific type of heart surgery called **minimally invasive aortic valve replacement via right anterior minithoracotomy** cannot participate. This is a less invasive surgery to replace a heart valve.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate. This is to ensure the safety and well-being of all participants.
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Investigated drugs

Interpectoral-Pectoserratus Plane Block (IPP-PSP) is a type of regional anesthesia used in this trial. It involves injecting anesthetic medication into specific areas between the chest muscles and the serratus muscle. This block is designed to provide pain relief for patients undergoing minimally invasive aortic valve replacement surgery. The goal is to reduce the need for other pain medications after surgery and improve patient comfort.

What is already known about the treatment

Interpectoral-Pectoserratus Plane Block – This is a regional anesthesia technique used to manage pain in patients undergoing minimally invasive aortic valve replacement surgery. It is administered through an injection in the chest area to block pain signals from reaching the brain. Currently, this method is being studied in clinical trials to evaluate its effectiveness compared to a placebo. The main therapeutic indication is to provide pain relief during and after heart valve surgery. The mechanism of action involves blocking nerve signals in the chest region, which helps reduce the sensation of pain. This technique falls under the pharmacological classification of regional anesthesia.

Investigated diseases

Aortic Valve Disease – Aortic valve disease involves the malfunction of the aortic valve, which is one of the four valves in the heart. This condition can lead to the valve not opening fully (stenosis) or not closing properly (regurgitation), affecting blood flow from the heart to the rest of the body. Over time, the heart may need to work harder to pump blood, potentially leading to symptoms such as shortness of breath, fatigue, and chest pain. As the disease progresses, it can cause the heart muscle to thicken or weaken. The severity of symptoms can vary, and some individuals may remain asymptomatic for years. Regular monitoring is essential to assess the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509786-21-00Estimated enrolment144 patientsSponsorAz Maria Middelares Gent

sourced from the EU Clinical Trials Register and site verification

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