AuthorisedTherapeutic confirmatory (Phase III)Interventional

Lidocaine for opioid sparing in vaso-occlusive crisis of Sickle Cell Disease

This study, for adults with sickle cell disease, wants to see if adding lidocaine, a pain-numbing medicine, can help reduce the amount of strong pain relief (like morphine) needed when they have a painful sickle cell crisis that needs hospital care. Researchers are comparing lidocaine combined with standard treatment to standard treatment alone. They will measure how much strong pain medicine patients use, how long they stay in hospital, and their pain levels. The aim is to find better ways to manage severe pain during sickle cell crises, potentially making patients more comfortable and helping them recover faster.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

104

Start

05 Nov 2025

Sickle cell disease

What is this study about?

Sickle cell disease can cause very painful episodes called vaso-occlusive crises, or pain crises, when sickle-shaped red blood cells block small blood vessels. These crises often need strong pain medicines, like morphine, given in hospital. This study is looking at a medicine called lidocaine, which is often used to numb areas for pain, to see if it can help reduce the need for these strong pain medicines during a crisis.

The main aim of the study is to find out if patients who receive lidocaine alongside their usual care use less strong pain medicine overall compared to those who only receive usual care. Researchers will carefully track the amount of strong pain relief, specifically morphine and oxycodone, that patients receive from when they join the study until they leave the intensive care unit. Using less strong pain medication could be a benefit for people experiencing these severe pain crises.

Beyond just pain relief, the study will also look at other important things. This includes how long people stay in the intensive care unit and in the hospital overall, how well their pain is controlled using special pain scores, and how quickly their crisis gets better. They will also check for any complications, how the treatment affects quality of life, and the cost-effectiveness of adding lidocaine. All of this information will help doctors understand if lidocaine could be a helpful and safe addition to current treatments for sickle cell pain crises.

Key takeaways

Targets adults with sickle cell disease experiencing a severe pain crisis.
Investigates if lidocaine reduces the need for strong pain medicine.
Compares lidocaine + usual care to usual care alone.
Measures pain levels, hospital stay, and quality of life.
Study participation lasts approximately 28 days.
Aims to find better ways to manage sickle cell pain crises.

Who may be eligible?

To be able to join this study, you must be an adult with sickle cell disease, aged 18 years or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to join the study.

The most important thing for joining is that you are currently experiencing a painful sickle cell crisis that requires hospital treatment and you are being considered for, or are already receiving, care in an intensive care unit. This study focuses on people who need significant care for their pain crisis.

Your medical team will check other specific health details to make sure this study is safe and right for you. They will review your medical history and current health condition carefully to ensure you meet all the necessary requirements to participate.

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?
Do you have a diagnosis of sickle cell disease?
Are you currently having a sickle cell pain crisis that requires hospital care?
Is your care team considering or currently admitting you to the intensive care unit for this crisis?
Your doctor will check other specific medical requirements.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your usual care for your sickle cell pain crisis. In addition to this, you would either receive lidocaine or a saltwater solution (which looks the same as lidocaine but has no active medicine) through a drip, alongside your usual care. This is done to fairly compare the two groups.

Throughout your time in the intensive care unit and hospital, the study team will closely monitor your pain levels, the amount of pain medication you receive, and how long you stay in hospital. They will regularly check on your condition to ensure your safety and track your progress.

There will also be follow-up assessments after you leave the hospital, including checking on your quality of life at 28 days through a questionnaire. The total duration of your active participation, including follow-up, will be around 28 days from when you join. You will have regular contact with the study team during this time.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving an investigational treatment (lidocaine) that might help reduce your pain or the amount of strong pain relief you need. However, there's no guarantee that you will personally benefit from being in the study. All medical treatments have potential risks, and the study team will carefully monitor you for any side effects from the lidocaine or the standard treatments. You will be told about all known risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time 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 lidocaine?

Lidocaine is a medicine often used as a local anaesthetic to numb parts of the body or to help with certain types of pain. In this study, it's given through a drip.

Why are you looking at lidocaine for sickle cell pain?

Doctors want to see if lidocaine can help reduce the need for strong opioid pain medicines, like morphine, during severe sickle cell pain crises, which could make patients more comfortable.

Will I still get my usual pain relief?

Yes, everyone in the study will still receive the standard, usual care for their sickle cell pain crisis, including other pain medications as needed by your medical team.

How long will I be involved in the study?

Your active participation, including hospital stay and follow-up, will last about 28 days from when you join the study.

What is 'standard of care'?

'Standard of care' refers to the best, most commonly accepted treatments currently used by doctors for your condition, based on medical evidence and guidelines.