Not yet recruitingPHASE4INTERVENTIONAL

LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients

This study, called LIDOCRIT, is investigating how a continuous drip of lidocaine, a common pain medication, can help patients after surgery who are in critical care. We're trying to find out if it can reduce their discomfort more effectively than existing pain relief methods, which often rely on morphine. While morphine works, it can have side effects like making patients too sleepy, which isn't always good for recovery. Lidocaine is known to lessen pain and has fewer side effects when used this way. The study hopes to improve patient comfort and overall recovery by using lidocaine, and we’ll measure this using a special questionnaire designed to understand patient well-being.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Rennes University Hospital

Enrolment target

246

Start

01 Oct 2025

Estimated completion

01 Jun 2028

Post-surgery Critical Incare

What is this study about?

When people are in intensive care after a big operation, managing their pain and making them comfortable is incredibly important. While we've made good progress in pain relief, doctors are always looking for even better ways to help patients feel more at ease without causing extra problems.

Often, strong painkillers like morphine are used, but sometimes these can make patients too drowsy. Being overly sleepy, especially in the first couple of days in intensive care, has been linked to a longer stay in hospital and sometimes even worse outcomes. That's why doctors are exploring different combinations of pain relief, especially those that don't rely solely on morphine.

This study, called LIDOCRIT, is testing a medicine called lidocaine. You might know lidocaine as a local anaesthetic used by dentists to numb small areas. However, when given as a continuous drip into a vein, it can also help with pain throughout the body, particularly a type of pain called 'hyperalgesia' where you feel pain much more strongly than you should. Previous research in surgery has shown that lidocaine can reduce pain after operations, mean less need for other strong painkillers, and even help with sickness. The aim of this study is to see if a continuous lidocaine drip for 48 hours can make patients more comfortable after surgery in critical care, based on what they tell us about their discomfort.

Key takeaways

The study aims to improve comfort for patients in critical care after surgery.
It's testing continuous lidocaine drip versus a dummy treatment for pain relief.
The goal is to reduce discomfort and possibly lessen the need for other strong painkillers.
Participation involves receiving a drip for 48 hours and being monitored.
Your comfort will be assessed using a special questionnaire.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be over 18 years old and admitted to critical care straight after an operation. We’d also expect you to stay in critical care for at least two days. You would also need to be part of a social security scheme in the UK, and either you or a close family member or legal representative would need to agree to you taking part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if you weigh over 100 kg, have a specific blood condition called acute porphyria, or are pregnant or breastfeeding. We also can't include you if you've had certain types of pain relief around your spine during or after surgery, or if you have severe head injuries, have recently recovered from a heart or breathing stop, or have very low heart rate due to medication. Certain kidney or liver problems, active seizures, or if you can't understand or answer questions because of language barriers or thinking difficulties, would also mean you couldn't take part. Lastly, if you're already in another medical research study or are under certain legal protections, you wouldn't be eligible.

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 over 18 years old?
Are you going into critical care right after surgery?
Do you expect to stay in critical care for at least 2 days?
Are you allergic to lidocaine or similar medicines?
Are you pregnant or breastfeeding?
Have you recently recovered from a heart or breathing stop?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive either a continuous drip of lidocaine or a dummy treatment (placebo) for 48 hours. This is given through a drip into your arm, similar to other medicines you might already be getting. Doctors will still choose other pain relief medicines (like morphine or similar drugs) for you based on your needs during this time, aiming to keep your pain at a comfortable level. You will be monitored closely from when you start the treatment until you leave critical care, up to a maximum of 30 days after your operation. If you go home before 30 days, we'll still check on your general health status on day 30.

Potential risks and benefits

While there's no guarantee the lidocaine will directly benefit you, it might improve your comfort after surgery. The main potential benefit is reducing your discomfort by providing effective pain relief, possibly reducing the need for other strong painkillers which have their own side effects. Lidocaine is generally safe when given this way, but like all medications, it has potential side effects. If you experience any worrying symptoms that might be linked to the lidocaine, the doctors will stop the drip immediately and check if it's related to the medicine. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (15)

CHU d'Angers - RCA (Réanimation Chirurgicale A)
Verified postcode
Angers, France
CHU d'Angers - RCB (Réanimation Chirurgicale B)
Verified postcode
Angers, France
CHU de Brest - Réanimation Cardiaque
Verified postcode
Brest, France
CH Louis Pasteur (Chartres) - Réanimation
Verified postcode
Chartres, France
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation Chirurgicale Polyvalente
Verified postcode
Nantes, France
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation CTCV
Verified postcode
Nantes, France
CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale
Verified postcode
Nantes, France
CHU de Poitiers - Réanimation Chirurgicale
Verified postcode
Poitiers, France
CHU de Rennes - Réanimation chirurgicale
Verified postcode
Rennes, France
CHU de Rennes - Réanimation CTCV
Verified postcode
Rennes, France
CH de Saint-Nazaire - Réanimation médico-chirurgicale - Unité de Surveillance Continue (USC)
Verified postcode
Saint-Nazaire, France
CHRU de Tours - Hôpital Trousseau - Réanimation Chirurgicale
Verified postcode
Tours, France

Common questions

What is lidocaine?

Lidocaine is a medicine that can numb pain. It's often used by dentists, but in this study, it's given as a drip to help with overall pain after surgery.

Why is this study important?

It's important because we want to find better ways to keep patients comfortable after surgery without making them too sleepy from other strong painkillers, which can slow down recovery.

Will I know if I'm getting lidocaine or the dummy treatment?

No, neither you nor your doctors will know. This helps us get accurate results without anyone's expectations influencing the outcome.

How long will the treatment last?

The lidocaine or dummy treatment will be given continuously for 48 hours (2 days).

What happens if I have side effects?

If you have any side effects that might be from the study medicine, the doctors will stop the drip immediately and check you over carefully.

How to find out more

Elodie MASSERET, MD

elodie.masseret@chu-rennes.fr +33 2 99 28 42 46 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.