Not yet recruitingPHASE3INTERVENTIONAL

Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease

This study is investigating if lidocaine can help patients with sickle cell disease who are experiencing a very painful crisis, known as a vaso-occlusive crisis. We're trying to find out if giving lidocaine, alongside their usual pain relief, can reduce the total amount of strong pain medications (like morphine) they need. This is important because strong pain medications can have side effects. Participants will receive either lidocaine, a dummy treatment (placebo), or their standard care. The aim is to see if lidocaine can make pain management more effective and potentially safer for people during these difficult times.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Nantes University Hospital

Enrolment target

104

Start

01 Mar 2026

Estimated completion

01 Apr 2028

Vaso-Occlusive Pain Episode in Sickle Cell Disease

What is this study about?

When people with sickle cell disease have a painful episode, it's called a vaso-occlusive crisis. These crises can be very severe and often require strong pain medications, such as opioids. While these medicines are important for pain relief, they can also come with side effects. This study is exploring a different approach to managing this intense pain.

The research is testing whether a medication called lidocaine, which is often used as a local anaesthetic, can help in these situations. The main question is whether adding lidocaine to the usual pain treatment can reduce the overall amount of strong opioid pain relievers that a patient needs. If it can, it might mean better pain control with fewer side effects from the strong medications.

Participants will be placed into different groups: some will receive lidocaine, some will get a placebo (a dummy treatment that looks like lidocaine but has no active medicine), and others will continue with their standard pain care. By comparing these groups, researchers hope to understand if lidocaine is a safe and effective way to help manage pain during a sickle cell crisis.

Key takeaways

This study explores a new way to manage severe pain in sickle cell crises.
It aims to see if lidocaine can reduce the need for strong pain medications.
You might receive lidocaine, a placebo, or standard care.
Your pain levels and medication use will be carefully monitored.
Participation is voluntary, and you can withdraw at any time.
The study is for adults (18+) with sickle cell disease in intensive care for a crisis.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of sickle cell disease. You also need to be in hospital, specifically in intensive care, because of a severe painful crisis (vaso-occlusive crisis) or a serious chest problem linked to sickle cell called Acute Chest Syndrome. You must have started strong pain medication (like morphine or oxycodone) in the last three days.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you're taking certain heart medications. You also can't take part if you've already been using lidocaine patches, or if you're allergic to lidocaine or similar medicines. The study is currently focused on people who speak French.

Don't worry if you're not sure if you qualify, the study team will carefully check all these points with you or your closest family member.

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 sickle cell disease (SS, SC, Sβ, or Sβ+)?
Are you currently in intensive care due to a sickle cell pain crisis or Acute Chest Syndrome?
Have you started strong pain medication (like morphine) within the last 72 hours?
Are you willing and able to give your consent to participate?
Are you not pregnant or breastfeeding?

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 pain relief. In addition, you will either receive the study drug (lidocaine), a dummy drug (placebo) that looks exactly like the study drug, or no additional study drug. You won't know which one you're getting, and neither will your doctors, to make sure the results are fair.

Throughout your time in the study, doctors and nurses will closely monitor your pain levels and any side effects. They will also keep track of how much strong pain medication you receive. There won't be any extra visits needed outside of your hospital stay. The study will last for the duration of your current hospital admission for the sickle cell crisis.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that lidocaine might help to better manage your pain and reduce the amount of strong pain medication you need, which could mean fewer side effects. However, it's also possible that lidocaine might not help, or you might experience side effects from it, although these are usually mild. You will be closely monitored by medical staff throughout the study. Remember, deciding whether to join is entirely your choice. You can say yes, or you can decide not to participate, or you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

CHU Bordeaux
Verified postcode
Bordeaux, France
CHU Lille
Verified postcode
Lille, France
CHU La Timone
Verified postcode
Marseille, France
CHU de Nantes
Verified postcode
Nantes, France
CHU Orléans
Verified postcode
Orléans, France
Hôpital Tenon APHP
Verified postcode
Paris, France
CHU Poitiers
Verified postcode
Poitiers, France
CHU Rouen
Verified postcode
Rouen, France
Oncopole Toulouse
Verified postcode
Toulouse, France
CHRU Tours - Hôpital Bretonneau
Verified postcode
Tours, France
CHU Guadeloupe
Verified postcode
Les Abymes, Guadeloupe

Common questions

What is a vaso-occlusive crisis?

It's a very painful episode that happens when sickle-shaped red blood cells block small blood vessels, causing severe pain in different parts of the body.

What is lidocaine?

Lidocaine is a medication often used as a local anaesthetic to numb parts of the body. Here, it's being tested to see if it can help with crisis pain.

What does 'opioid sparing' mean?

It means the study is trying to find out if using lidocaine can reduce the amount of strong pain medications, like morphine, that a person needs.

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

No, neither you nor your doctors will know, to make sure the study results are as fair and accurate as possible. This is called 'blinding'.

How long will I be in the study?

You will be part of the study for the duration of your hospital stay for the current painful crisis.

How to find out more

Maïté AGBAKOU

maite.agbakou@chu-nantes.fr 02.44.76.80.54 Official trial record

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