AuthorisedTherapeutic use (Phase IV)Interventional

High versus low dose serratus anterior plane block after minimally invasive valve surgery: a double-blinded randomized controlled trial

This research is investigating the best dose of a special pain-numbing injection, called a serratus anterior plane block, given after keyhole heart valve surgery (aortic valve replacement). The pain-numbing injection is made from a medicine called Marcaine, mixed with adrenaline. Researchers want to compare a higher dose with a lower dose to see which one is more effective at managing pain. They will carefully check how much powerful pain medicine (morphine) patients need in the 24 hours after surgery. The goal is to find a way to help people have less pain, feel more comfortable, and recover faster after their heart operation. This is a Phase IV study, meaning it's looking at treatments already used, but in a new way or comparing different doses.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Jessa Ziekenhuis

Enrolment target

100

Start

12 Feb 2024

Serratus anterior plane block after an aortic valve replacement

What is this study about?

This study is all about finding the best way to manage pain after a common heart operation called an aortic valve replacement, particularly when it's done using a less invasive (keyhole) method. When you have this surgery, doctors might give you a special pain-numbing injection called a serratus anterior plane block. This injection helps to block pain signals from the chest area.

In this research, doctors want to see if using a higher dose of the pain-numbing medicine (Marcaine, with a small amount of adrenaline) works better than a lower dose. They will carefully watch how much other strong pain medicine, like morphine, patients need in the first 24 hours after surgery. This is important because needing less strong pain medicine can mean better comfort and fewer side effects like sickness or constipation.

The main goal is to improve how patients feel after their operation. They will also look at other things like how satisfied patients are with their pain relief, how quickly they can move around, if they feel sick, and how soon they can go home. By understanding the best dose for this pain-numbing injection, doctors hope to make recovery smoother and more comfortable for people undergoing heart valve surgery.

Key takeaways

This study helps improve pain relief after keyhole heart valve surgery.
It compares two different doses of a pain-numbing injection.
The main goal is to reduce the need for strong pain medicines like morphine.
Researchers will also check satisfaction, recovery, and how quickly patients go home.
Participation could help improve care for future heart surgery patients.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who are having a minimally invasive (keyhole) aortic valve replacement surgery.

This means if you're having a different type of heart surgery, or if you're younger than 18, or if your doctors decide that this particular pain-numbing injection isn't suitable for you for other medical reasons, you wouldn't be able to join this specific study. Your medical team will check details of your health and planned surgery to see if you fit the study's requirements.

The most important detail is that you are scheduled for a keyhole aortic valve replacement, as the study focuses on pain relief specifically for this procedure.

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 'keyhole' (minimally invasive) aortic valve replacement surgery?
Are you willing to have a pain-numbing injection as part of your pain management?
Are you able to provide your feedback on pain levels and satisfaction?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the pain-numbing injection (serratus anterior plane block) either with a higher or lower dose of medicine, which your doctors will decide. This injection is given as part of your pain relief plan after your heart valve surgery. For the first 24 hours after the injection, your medical team will carefully record how much strong pain medicine (like morphine) you use through a special pump you control, called a PCIA system. They will look at these records in 4-hour blocks.

Beyond just tracking pain medicine, nurses or doctors will also ask you to rate your pain using a simple 0-10 scale at different times (4, 8, 12, and 24 hours after the block, and again about a week later). They'll ask about your pain at rest and when you take a deep breath. You'll also be asked to rate your overall satisfaction with your pain relief at 24 hours and on the first day after surgery. The team will also monitor other aspects of your recovery, such as when you first move around, when you can leave the intensive care unit, and when you are ready to go home. All these measurements will help the researchers understand the benefits of the different doses. The total duration of your active participation, in terms of measurements and observations, will mainly be during your hospital stay, with a follow-up pain check about a week later.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might receive the dose of pain-numbing medicine that is found to be most effective for pain relief after your surgery, which could lead to a more comfortable recovery. It also helps future patients by improving our understanding of pain management. As for risks, the injection itself carries small risks, similar to any medical procedure, like bruising or a slight chance of infection. These are carefully managed by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. Your doctors will discuss all potential risks and benefits specific to you before you make a decision.

Locations (1)

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

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Unverified
Belgium

Common questions

What is a 'serratus anterior plane block'?

It's a special injection given after surgery to numb the nerves in your chest area, helping to control pain from your operation.

Why are they comparing two different doses?

Doctors want to find out if a higher dose or a lower dose of this pain-numbing medicine works best to reduce pain after your heart surgery.

What is 'PCIA' and 'morphine consumption'?

PCIA stands for Patient-Controlled Intravenous Analgesia. It's a pump that lets you give yourself small, safe doses of strong pain medicine like morphine when you need it. 'Morphine consumption' just means how much morphine you've used.

Will I know if I'm getting the high or low dose?

No, this is a 'double-blinded' study, meaning neither you nor your doctors will know which dose you're receiving. This helps make the study results fair.

Is this a new type of treatment?

The medicine itself is already used, but this study is looking at using it in a specific way (after this type of heart surgery) and comparing different doses to find the best approach for pain relief.