Study of lidocaine to reduce opioid use in patients with sickle cell disease experiencing severe pain crisis

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What is this study about?

This study involves people with Sickle Cell Disease who are experiencing a painful condition called vaso-occlusive crisis, which happens when blood vessels become blocked and cause severe pain in different parts of the body. Some patients may also develop acute chest syndrome, which causes breathing problems and chest pain along with changes visible on chest imaging. The study will compare two treatment approaches for managing pain during these severe episodes. One group will receive lidocaine hydrochloride along with standard pain treatment, while the other group will receive sodium chloride along with standard pain treatment. Both medications will be given as injections. Standard pain treatment typically includes strong pain medications called opioids, such as morphine or oxycodone, which are given through a vein.

The purpose of this study is to find out whether adding lidocaine to the usual pain management can reduce the total amount of opioid pain medication needed during a severe vaso-occlusive crisis. The study will measure the total amount of opioid medication used from the time patients join the study until they leave the intensive care unit, where they receive care for their condition.

Patients who take part will be admitted to the intensive care unit for treatment of their vaso-occlusive crisis or acute chest syndrome. They will receive either lidocaine or sodium chloride in addition to their standard pain treatment for up to three days. During their stay in the intensive care unit, doctors will monitor their pain levels, how much pain medication they need, and how long it takes for their crisis to improve. The study will also track how long patients stay in the intensive care unit and in the hospital overall, whether any complications develop, and their quality of life after 28 days. Researchers will look at whether patients need additional hospital visits or emergency room care within the first month after joining the study.

1 Enrollment and treatment start

Upon joining the study, you will already be receiving treatment with morphine or oxycodone through an injection or intravenous line. This treatment will have been started within the previous 72 hours.

You will be randomly assigned to receive either lidocaine hydrochloride added to your standard pain treatment, or standard pain treatment alone. Lidocaine is a medication that can help reduce pain.

Your treatment will take place in the intensive care unit, which is a specialized hospital area for patients requiring close monitoring.

2 Treatment during intensive care unit stay

You will continue to receive pain medication through injections or intravenous line as needed. The medications used are morphine or oxycodone, which are strong pain relievers called opioids.

If you are assigned to the lidocaine group, you will also receive lidocaine hydrochloride along with sodium chloride solution through an intravenous line.

Your pain levels will be assessed regularly using a Visual Analogue Scale and a Categorical Pain Score. These are tools that help measure how much pain you are experiencing.

The medical team will monitor your temperature, ability to move without pain, and whether you still need continuous pain medication through an intravenous line.

You will remain in the intensive care unit until your condition improves. The crisis is considered resolved when at least three of the following occur: no fever for the last 8 hours, no need for continuous intravenous pain medication for the last 8 hours, ability to walk or move without pain, and minimal or no spontaneous pain.

3 Discharge from intensive care unit

Once your condition has improved sufficiently, you will be discharged from the intensive care unit.

The total amount of pain medication you received during your intensive care unit stay will be recorded.

You may be transferred to a regular hospital ward or discharged home, depending on your condition.

4 Follow-up at 28 days

At 28 days after joining the study, you will complete a questionnaire called the Adult Sickle Cell Quality of Life Measurement Information System. This questionnaire assesses how sickle cell disease affects your daily life and well-being.

Information will be collected about any side effects or complications you may have experienced.

Information will be collected about any hospital readmissions or emergency room visits that occurred during this period.

Who Can Join the Study?

You must be 18 years of age or older
You must have a confirmed diagnosis of sickle cell disease, which is an inherited blood disorder where red blood cells become abnormally shaped, with one of these specific types: SS, SC, Sβ0, or Sβ+
You must be admitted to the intensive care unit, which is a specialized hospital area for patients needing close monitoring, for one or both of these reasons: vaso-occlusive crisis, which means severe pain caused by blocked blood vessels due to abnormally shaped red blood cells, affecting areas like arms, legs, ribs, chest bone, head, spine, or pelvis, and not caused by another condition, or acute chest syndrome, which is a serious lung complication that includes breathing problems such as shortness of breath or chest pain or abnormal lung sounds, along with new signs of lung problems seen on chest x-ray, CT scan, or ultrasound
You must have started receiving morphine or oxycodone, which are strong pain medications given through a vein or injection, less than 72 hours before joining the study
You or your family member must be informed about the study and agree to your participation, or if you cannot make decisions and no family member is available, a doctor can include you in the study as an emergency procedure
You must be able to speak and understand French
You must have health care insurance

Who Cannot Join the Study?

The study information does not list specific reasons why patients cannot participate in this trial
If you have sickle cell disease, which is a condition affecting red blood cells, you should speak with the research team to learn about any restrictions that may apply to you
General exclusion reasons are not provided in the available study details

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Aix Marseille University	Marseille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cluazf Hgoyvkfokhc Rgdkqbug Ujoszsvtajhws Du Tnuen	Tours	France
Ckkcei Huwdpfsylsl Usdyacyswldqr dw lm Gzlbkcjuga	Pointe A Pitre	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

Lidocaine is a medication that works as a numbing agent to help reduce pain. In this trial, it is being tested to see if it can help reduce the amount of strong pain medications (opioids) needed when someone with Sickle Cell Disease is experiencing a severe pain crisis.

Opioids are strong pain relief medications that are commonly used to treat severe pain. In this trial, they are part of the standard treatment for pain during a vaso-occlusive crisis in Sickle Cell Disease. The study is looking at whether adding lidocaine can help reduce how much of these medications patients need.

Investigated diseases:

Sickle cell disease

Sickle Cell Disease – Sickle cell disease is an inherited blood disorder that affects the shape and function of red blood cells. In this condition, red blood cells become rigid and shaped like crescents or sickles instead of being round and flexible. These abnormally shaped cells can block blood flow through small vessels, causing episodes of pain called vaso-occlusive crises. During these crises, the blocked blood flow prevents oxygen from reaching tissues and organs, leading to severe pain and potential complications. The disease is present from birth and affects the body throughout a person’s life. People with sickle cell disease may experience periods of relatively good health interrupted by painful episodes and various complications affecting multiple organs.

Trial ID:

2024-518437-28-00

Protocol code:

RC24_0427

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of lidocaine to reduce opioid use in patients with sickle cell disease experiencing severe pain crisis

What is this study about?

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