AuthorisedTherapeutic confirmatory (Phase III)Interventional

SERRATUS : Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.

This research, called SERRATUS, is a vital study (Phase III) focusing on new ways to manage pain for patients in intensive care. Specifically, it's for people who need a chest drain to remove fluid from around their lungs. The study investigates if a special pain relief technique called a 'serratus plane block' can effectively reduce pain during this procedure. Researchers are testing a combination of anaesthetic medicines (Dexamethasone Sodium Phosphate, Ropivacaine, and Lidocaine Hydrochloride) to see how well they work. The main goal is to measure how much pain patients feel right after the drain is put in, and also to monitor pain levels, breathing, and recovery for the first 24 hours.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

Start

30 Jul 2024

Anesthesia /Intensive care

What is this study about?

This study, called SERRATUS, is looking into how best to reduce pain for patients in the intensive care unit (ICU) who need a procedure called 'pleural drainage'. This is when doctors insert a tube into the chest to drain away fluid that has built up around the lungs. This can be quite uncomfortable, and the researchers want to find a better way to keep patients comfortable.

The main idea behind this study is to test a specific pain relief method called a 'serratus plane block'. This involves giving a local anaesthetic injection in a particular area of the chest, which aims to numb the nerves that cause pain during and after the drainage. The study will be comparing a combination of different pain-relieving medicines to see which is most effective at reducing pain.

The doctors involved in the study will carefully monitor how much pain patients feel using a simple pain scale. They will also look at how patients recover, checking their breathing, how quickly they can start moving around, and if there are any complications. This information will help them understand if this pain relief method can make a real difference to patients' comfort and recovery in the ICU.

Key takeaways

Tests new pain relief for chest drains.
Aims to improve comfort in intensive care.
Compares specific pain medication combinations.
Monitors pain, breathing, and recovery closely.
Participation is voluntary for adults aged 18+.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, meaning older adults are also welcome to participate.

Both men and women can take part in this research.

The study is specifically for patients who are currently in the intensive care unit and need a procedure called pleural drainage, where fluid is removed from around their lungs.

Quick self-check

Are you 18 years old or older?
Are you currently an intensive care patient?
Do you need a chest drain to remove fluid from around your lungs?
Are you able to understand and consent to participating in research?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the doctors will use specific pain relief medicines (Dexamethasone Sodium Phosphate, Ropivacaine, and Lidocaine Hydrochloride) as part of your serratus plane block. Your pain levels will be regularly checked using a simple numerical scale, both when you're resting and when you do gentle movements like taking a deep breath or coughing, especially right after the chest drain is put in and for the next 24 hours (at 1, 6, and 24 hours).

Your vital signs like heart rate, breathing rate, and oxygen levels will be monitored. Doctors will also measure your lung capacity, check for any breathing complications like lung collapse or lung infection, and note if you need help with breathing from a machine. They will also track how quickly you can get up and move around, how long the chest drain stays in, how long you stay in intensive care, and how long it takes for the anaesthesia to be given. The total duration of your active participation for observation will be at least 24 hours following the chest drain insertion.

Potential risks and benefits

Taking part in this study could potentially lead to better pain control during and after your chest drainage procedure, which might improve your comfort and recovery. As with any medical procedure, there are potential risks associated with the injections and medicines used, such as bleeding, infection, or side effects from the drugs. However, the medical team will monitor you closely. Remember, your participation is completely voluntary; you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

—
France

Common questions

What is pleural drainage and why might I need it?

Pleural drainage is a procedure where a tube is inserted into your chest to remove excess fluid that has built up around your lungs. This is often done if fluid is making it hard for you to breathe.

What is a 'serratus plane block'?

It's a type of local anaesthetic injection given in a specific area of your chest. The aim is to numb the nerves that cause pain, providing relief during and after your chest drain procedure.

What kind of pain medicines are being tested?

The study is looking at a combination of medicines called Dexamethasone Sodium Phosphate, Ropivacaine, and Lidocaine Hydrochloride. These are common pain-relieving drugs.

How will my pain be measured?

Your pain will be measured using a simple numerical scale, where you rate your pain level. This will be done both when you're resting and during gentle movements like taking a deep breath.

Will I have to stay in the hospital longer if I join?

The study is designed to observe your pain relief and recovery during your existing stay in the intensive care unit. It is not expected to lengthen your hospital stay.