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Study on the Effect of Ropivacaine on Breathing After Heart Surgery for Patients Undergoing Cardiac Surgery

Verified siteRegistered drugNo placebo
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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 patients undergoing cardiac surgery, specifically those who have a procedure called a sternotomy, which involves opening the chest to access the heart. The study is investigating the effects of a treatment called a para-sternal block, which is a type of local anesthesia that numbs the area around the sternum to help manage pain after surgery. The medication used for this block is called Ropivacaine, which is a local anesthetic that helps reduce pain by blocking nerve signals in the body.

The purpose of the study is to compare how this type of anesthesia affects breathing function after surgery. Participants will be randomly assigned to receive either the para-sternal block with Ropivacaine or a placebo. The study will monitor participants' breathing and pain levels at various times after surgery, including the first day, the second day, and two months later. Breathing function will be measured using a test called spirometry, which checks how well the lungs are working by measuring the amount of air a person can exhale.

Throughout the study, researchers will also assess pain levels using a simple scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. Other aspects of recovery, such as the need for additional pain medication and any complications related to breathing, will also be monitored. The study aims to provide valuable information on whether the para-sternal block with Ropivacaine can improve recovery and comfort for patients after cardiac surgery.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written consent and meeting the criteria: being over 18 years old and scheduled for elective cardiac surgery with sternotomy.

  2. Step 2

    Preoperative assessment

    Before surgery, a measurement of your lung function, called forced vital capacity (FVC), is taken using a device called a spirometer. This will help compare your lung function before and after surgery.

  3. Step 3

    Surgery and anesthesia

    During your cardiac surgery, a type of pain relief called a para-sternal block is administered. This involves an injection of a medication called ropivacaine near the sternum to help manage pain after surgery.

  4. Step 4

    Postoperative day 1

    On the first day after surgery, your lung function is measured again to assess any changes in your forced vital capacity (FVC) compared to the preoperative measurement.

  5. Step 5

    Pain assessment

    Pain levels are evaluated at 6, 12, 24, 30, and 48 hours after surgery using a numerical scale from 0 (no pain) to 10 (severe pain).

    Daily pain assessments continue from day 3 to day 7, once between 8 a.m. and 12 p.m.

  6. Step 6

    Respiratory function monitoring

    Lung function is monitored on the second day after surgery and again two months later. Measurements include various lung function parameters such as FVC and FEV1 (forced expiratory volume in one second).

  7. Step 7

    Monitoring for complications

    For two months after surgery, monitoring for potential lung-related complications occurs. These include infections, respiratory failure, and other conditions affecting lung function.

  8. Step 8

    Pain management and medication

    The use of pain relief medications like morphine or oxycodone is tracked over the first 48 hours after surgery.

  9. Step 9

    Hospital stay and discharge

    The length of your hospital stay is recorded, from admission to discharge.

  10. Step 10

    Chronic pain assessment

    Two months after surgery, an assessment of any ongoing pain is conducted using a specific questionnaire.

Who can join the trial?

5 criteria

  • Patients must be **over 18 years of age**.
  • Patients must be scheduled for **elective cardiac surgery**. This means a planned heart surgery, not an emergency one.
  • The surgery must involve a **sternotomy**, which is a surgical procedure where the chest is opened to access the heart.
  • The types of surgeries included are **valve replacement**, **coronary artery bypass graft**, or a combination of both.
  • Patients must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

  • Patients who have had cardiac surgery cannot participate. This means if you have had surgery on your heart, you are not eligible.
  • Patients who are under 18 years old cannot participate. This means only adults can join the study.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.
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Investigated drugs

Para-sternal Block is a type of locoregional anesthesia used in this clinical trial. It involves injecting anesthetic near the sternum to block pain in the chest area. This method is being evaluated for its effectiveness in improving respiratory function after cardiac surgery. The goal is to see if this type of pain management can help patients breathe better after their operation.

What is already known about the treatment

Para-sternal Block – This medication is administered through a local anesthetic injection near the sternum, typically used during cardiac surgery. It is currently being studied in clinical trials to assess its effectiveness in improving postoperative respiratory function. The main therapeutic indication is to provide pain relief after sternotomy, a common procedure in cardiac surgery. The mechanism of action involves blocking nerve signals in the chest area, which helps reduce pain and improve breathing post-surgery. It is classified as a local anesthetic in pharmacology.

Investigated diseases

  • Respiratory Infection

    This condition involves an infection in the respiratory tract, which can lead to symptoms such as cough, fever, and difficulty breathing. It often results in the production of sputum and may cause changes in lung imaging, such as new or altered opacities. The infection can be caused by bacteria, viruses, or other pathogens, and it may require antibiotic treatment if bacterial in nature.

  • Respiratory Failure

    This condition occurs when the lungs cannot provide enough oxygen to the blood or remove carbon dioxide from it. It is characterized by low oxygen levels in the blood, which can lead to symptoms like shortness of breath and confusion. Respiratory failure may require supplemental oxygen or mechanical ventilation to support breathing.

  • Atelectasis

    This condition involves the collapse of part or all of a lung, leading to reduced gas exchange and breathing difficulties. It is often identified by imaging studies showing lung opacification and displacement of structures like the mediastinum. Atelectasis can result from blockages, pressure on the lung, or other factors affecting lung expansion.

  • Bronchospasm

    This condition is characterized by the narrowing of the airways due to muscle contraction, leading to wheezing and difficulty breathing. It is often triggered by allergens, irritants, or respiratory infections and can be relieved with bronchodilators. Bronchospasm is commonly associated with asthma and other respiratory conditions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513301-30-00Estimated enrolment84 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

sourced from the EU Clinical Trials Register and site verification

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