Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Evaluation of the effect of para-sternal block on postoperative respiratory function after sternotomy cardiac surgery. Prospective, controlled, randomized, single-blind study with independent assessment of outcome

This research trial is investigating whether a special injection called a para-sternal block can help people recover their breathing and reduce pain after heart surgery. Heart surgery often involves a cut down the breastbone (sternum), which can make breathing uncomfortable afterwards. The para-sternal block aims to numb the area, potentially making it easier to take deep breaths. Researchers will compare patients who receive this block with those who don't, to see if there's a difference in how well their lungs work and how much pain they experience in the days and months following surgery. The goal is to find better ways to support patients' recovery after these important operations.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

Start

07 May 2024

cardiac surgery

What is this study about?

When you have heart surgery, doctors often need to make a cut down the middle of your chest, through your breastbone. This is called a sternotomy. While the surgery itself is vital, recovering from this cut can sometimes make it hard to take deep breaths because of pain or discomfort.

This study is looking at a specific technique called a 'para-sternal block'. This is an injection that numbs the nerves around the breastbone, aiming to reduce pain in that area. Researchers want to find out if giving this block to patients before or after their heart surgery can help them breathe more easily and recover their lung function faster. They will also be carefully monitoring how much pain patients feel.

They'll measure lung strength and capacity using a simple breathing test, look at pain levels, and check for any breathing problems in the weeks and months after surgery. By comparing patients who receive this block with those who don't, the doctors hope to learn if this method can make a real difference to patient comfort and recovery after heart surgery.

Key takeaways

Tests a pain-blocking injection for heart surgery recovery.
Aims to improve breathing and reduce pain after surgery.
Compares patients with and without the special injection.
Measures lung function and pain levels for two months.
Results could help future patients recover better.

Who may be eligible?

This study is open to both men and women who are aged 18 or older. There is no upper age limit for taking part.

To be eligible, you would need to be undergoing cardiac (heart) surgery. The specific type of heart surgery would be one that involves a cut through the breastbone (sternum).

Your medical team will be able to review your full health history to confirm if this study is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having heart surgery?
Does your heart surgery involve a cut through your breastbone?
Are you comfortable with regular breathing tests and pain assessments after your operation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the para-sternal block injection as part of the trial. Your breathing ability would be measured before your surgery, and then again one day, two days, and two months after your operation using a special breathing machine. You would also be asked to rate your pain regularly in the first week after surgery, and your medical team would monitor you for any breathing complications for up to two months. The total duration of your participation, including follow-up, would be around two months.

Potential risks and benefits

Potential benefits of taking part could include better pain control and potentially improved breathing after your heart surgery, which could lead to a smoother recovery. As with any medical procedure, there are always potential risks; your doctor will discuss any specific risks associated with the para-sternal block with you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a para-sternal block?

It's an injection near your breastbone that numbs the area to help reduce pain, especially after chest surgery.

Why is this study important?

It aims to find better ways to help people breathe more easily and have less pain after heart surgery, which can improve their recovery.

What is 'forced vital capacity'?

This is a measure of how much air you can breathe out forcefully after taking a deep breath. It shows how well your lungs are working.

Will I definitely receive the special injection?

This is a randomised study. This means some patients will receive the block, and some won't, to see if there's a difference. You won't know which group you are in.

How long will I be involved in the study?

Your involvement, including check-ups, will last about two months after your surgery.