Study of Ropivacaine for Pain Control in Patients Having Open Heart Surgery Through Chest Bone Incision

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What is this study about?

This study focuses on pain management in patients undergoing cardiac surgery through a procedure called median sternotomy (an opening of the chest through the breastbone). The research examines the effectiveness of a pain-blocking technique called superficial parasternal intercostal plane block, which is a way to deliver numbing medication to the chest area after heart surgery.

The study uses two medications: ropivacaine hydrochloride (a local anesthetic that numbs specific areas) and sodium chloride solution (salt water). Some patients will receive the pain-blocking medication, while others will receive placebo. The purpose is to determine if this nerve-blocking technique can improve recovery after heart surgery.

During the study, patients will receive injections on both sides of their chest after surgery. Their recovery will be monitored through various assessments, including pain levels and overall well-being. The research team will evaluate how well patients recover in the first few days after surgery and follow up with them for one month to assess their healing progress.

1 Initial evaluation

Your eligibility for the cardiac surgery study will be confirmed based on specific criteria, including being at least 18 years old and scheduled for cardiac surgery through conventional median sternotomy.

Your cardiac risk will be evaluated using the European System for Cardiac Operative Risk Evaluation (EuroSCORE 2), which must be 3% or lower.

2 Surgery day preparation

Before the surgery, you will be randomly assigned to receive either the study treatment or a placebo.

The treatment involves a parasternal intercostal plane block, which is an injection near the breastbone to help manage post-surgical pain.

3 Medication administration

You will receive either an injection of ropivacaine (pain medication) or saline solution (placebo) on both sides of your breastbone.

The medication will be administered through perineural use (around the nerves) using an injection solution.

4 Post-surgery monitoring

Your recovery will be monitored for 72 hours after surgery.

Pain levels will be assessed at specific times: 3, 6, 12, 24, 48, and 72 hours after surgery.

Your need for additional pain medication will be recorded.

Medical staff will monitor for any breathing difficulties requiring special oxygen support.

5 Recovery assessment

You will complete a Quality of Recovery questionnaire 24 hours after surgery.

A second recovery assessment will be conducted on day 2 after surgery.

The time spent in intensive care and hospital will be documented.

6 Follow-up evaluation

A final health assessment will be conducted 30 days after surgery using a standardized questionnaire.

Who Can Join the Study?

You must be willing to provide written informed consent to participate in the study before any screening procedures begin
You must be at least 18 years old when signing the consent form
You must be scheduled for heart surgery through the breastbone (a procedure called median sternotomy, which involves making an incision through the middle of the chest)
Your surgical risk score (EuroSCORE 2) must be 3% or less (this is a calculation that estimates the risk of death after heart surgery based on various health factors)
You must be able to speak Dutch
Both men and women can participate in this study

Who Cannot Join the Study?

Age under 18 or over 65 years
Known allergies to local anesthetic medications
Previous chest surgery or significant chest trauma
Coagulation disorders (blood clotting problems)
Active infection at the site of planned injection
Inability to provide informed consent
Chronic pain syndrome affecting the chest area
Current use of strong pain medications (opioids)
Body mass index (BMI) above 40
Severe heart, lung, or kidney disease that could affect recovery
Pregnancy or breastfeeding
Emergency cardiac surgery cases
Participation in another clinical trial within the past 30 days
Known history of drug or alcohol abuse
Significant psychiatric disorders that could affect participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Az Maria Middelares Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Superficial parasternal intercostal plane (SPIP) block is a type of regional anesthesia technique where local anesthetic is injected into the space between the chest muscles near the breastbone. This nerve block is designed to reduce pain after heart surgery, specifically in the area where surgeons make an incision through the breastbone. The technique aims to provide pain relief by numbing the nerves that supply sensation to the front of the chest wall.

Local anesthetic is a medication that temporarily blocks pain signals in a specific area of the body. In this procedure, it is injected into the chest area to provide targeted pain relief after cardiac surgery. This helps patients experience less pain during their recovery period and may reduce the need for other pain medications.

Post-Sternotomy Pain – A condition that occurs after a surgical procedure where the sternum (breastbone) is cut vertically to access the heart. Pain develops along the incision line and surrounding chest area, with varying intensity during movement, breathing, and coughing. The condition typically affects the central chest region and may extend to nearby areas due to tissue manipulation during surgery.

Post-operative Nausea and Vomiting (PONV) – A common condition that occurs after surgery and anesthesia, characterized by feelings of queasiness and episodes of vomiting. It typically develops within the first 24 hours after surgery. The condition can vary in intensity and duration, affecting patient comfort and recovery time.

Respiratory Complications – A group of breathing difficulties that can develop after major chest surgery. These complications can include reduced lung capacity, difficulty taking deep breaths, and accumulation of secretions in the airways. The condition may affect breathing efficiency and oxygen levels in the body.

Trial ID:

2025-522135-34-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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