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AuthorisedTherapeutic use (Phase IV)Interventional

Morphine PCA vs Morphine and Lidocaine PCA for the treatment of vaso-occlusive crisis-related pain in sickle-cell anaemia patients: a prospective, randomized, double blind monocentric trial.

If you have sickle cell anaemia and experience painful crises, this study might be of interest. It's looking at different ways to manage that pain. Specifically, researchers want to see if adding another medicine called lidocaine to the usual morphine treatment can help reduce how much morphine is needed. This could be important because using less morphine might mean fewer side effects. The study aims to find out if this combination offers a better way to control pain during a sickle cell crisis while also monitoring how the treatments affect your body and whether there are any unwanted side effects.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
CHU Saint Pierre
Enrolment target
40
Start
26 Jan 2026

What is this study about?

This study is designed for people with sickle cell anaemia who experience very painful episodes, often called vaso-occlusive crises. When these crises happen, people usually receive strong pain relief, like morphine, through a pump they can control.

The researchers want to compare two ways of managing this pain. One group of patients will receive morphine as usual. Another group will receive morphine combined with a different medicine called lidocaine. Lidocaine is sometimes used to numb areas or help with pain, and the doctors want to see if adding it to morphine can make the morphine more effective.

The main goal is to find out if the group receiving the morphine-lidocaine combination needs less morphine overall to get their pain under control. They will also be checking how the treatments affect your body chemistry, how well your pain is controlled (using a simple pain score), and whether either treatment causes any side effects. This research is considered a "Phase IV" study, which means the medicines are already approved and widely used, and this study is looking at new ways to use them or compare them in real-world settings.

Key takeaways

  • Study compares morphine alone to morphine + lidocaine for sickle cell crisis pain.
  • Aims to see if the combination reduces the amount of morphine needed.
  • Participation is for adults (18+) with sickle cell anaemia experiencing a crisis.
  • Involves receiving medication via a controlled pump and pain level checks.
  • Researchers will monitor how well pain is controlled and any side effects.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to join if they meet other criteria. Both men and women can participate in this research.

Because this study is specifically about pain from sickle cell anaemia crises, you would need to have a confirmed diagnosis of sickle cell anaemia and be experiencing a vaso-occlusive crisis at the time of the study.

There might be other specific health requirements or conditions that would mean you can or cannot take part, but these details are usually discussed with the study doctor.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of sickle cell anaemia?
  3. Are you currently experiencing a vaso-occlusive (pain) crisis?
  4. Are you able to understand and agree to participate in the study?
  5. Are you willing for doctors to monitor your pain and take blood samples?
Answer every question to see your result.

What does participation involve?

If you join this study, your doctor will discuss whether you receive morphine alone or morphine mixed with lidocaine for your pain crisis. Both medicines would be given through a pump that you control, allowing you to give yourself pain relief when needed. You wouldn't know which combination you are receiving, nor would the doctors treating you, to ensure the results are fair.

Throughout your crisis, doctors and nurses will regularly check your pain levels using a simple scale and take blood samples to look at certain body markers. They will also carefully watch for any side effects associated with the medicines. The total duration of your participation would be during the period you are receiving pain relief for your crisis and potentially for a short follow-up after your crisis resolves to ensure you are well.

Potential risks and benefits

Participating in this study might offer the potential benefit of better pain control or the chance to use less morphine during a sickle cell crisis, which could lead to fewer common morphine side effects like drowsiness or sickness. However, as with any medical treatment, there are potential risks. Lidocaine, though generally safe, could have its own side effects, and the combination might react differently for some people. All potential risks will be thoroughly explained by the study team. You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected if you choose to do so.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Belgium

Common questions

What is sickle cell anaemia?

Sickle cell anaemia is a genetic blood disorder where red blood cells are shaped like a crescent moon instead of round. These unusual cells can get stuck in small blood vessels, causing severe pain (crises) and other health problems.

What is a vaso-occlusive crisis?

This is a very painful episode common in people with sickle cell anaemia. It happens when the sickle-shaped red blood cells block small blood vessels, stopping blood flow to parts of the body.

What is morphine PCA?

PCA stands for 'Patient-Controlled Analgesia'. It's a method where you can press a button to give yourself a small, safe dose of pain medication, like morphine, through an IV when you need it. Doctors set limits to prevent overdosing.

What is lidocaine and how does it help?

Lidocaine is a medicine often used as a local anaesthetic to numb areas or help with pain. In this study, doctors want to see if adding a small amount of it to morphine can make the pain relief more effective, potentially reducing the need for high doses of morphine.

Will I know which treatment I'm getting?

No, in this study, neither you nor your doctors will know if you are receiving morphine alone or morphine with lidocaine. This is called 'double-blind' and it helps ensure the study results are fair and unbiased.

How to find out more

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

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