Comparing morphine alone to morphine and lidocaine for pain relief in sickle cell anemia patients with vaso-occlusive crisis

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What is this study about?

This study involves patients with sickle cell anaemia who experience a painful complication called a vaso-occlusive crisis, which occurs when blood flow is blocked in blood vessels, causing severe pain. The study will compare two different pain treatment approaches. One group of patients will receive morphine hydrochloride alone, which is a strong pain medication, while the other group will receive a combination of morphine hydrochloride and lidocaine hydrochloride, which is a local numbing medication. Both treatments will be given through a vein using a method called patient-controlled analgesia, which allows patients to control their own pain medication doses within safe limits set by doctors.

The purpose of the study is to find out if adding lidocaine hydrochloride to morphine hydrochloride can reduce the total amount of morphine needed to control pain during a vaso-occlusive crisis. The study is designed so that neither the patients nor the doctors will know which treatment each patient is receiving during the trial, which helps ensure fair results. Patients will be randomly assigned to receive either the combination treatment or morphine alone.

During the study, researchers will measure how much morphine each patient uses, track changes in pain levels using a pain rating scale, monitor certain substances in the blood that may indicate how the body is responding to treatment, and watch for any unwanted effects that morphine might cause. The study will help doctors understand whether combining these two medications provides better pain relief with less morphine compared to using morphine by itself.

1 Random assignment to treatment group

Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fairness in the study.

The study is double blind, which means neither you nor your doctor will know which specific treatment group you are in during the trial.

2 Pain management treatment begins

You will receive pain medication through a device called PCA, which stands for patient-controlled analgesia. This device allows you to control when you receive pain medication by pressing a button.

The medication will be given through a vein in your body, which is called intravenous bolus use. A bolus means a single dose of medication delivered at one time.

One group will receive morphine hydrochloride alone through the PCA device.

The other group will receive a combination of morphine hydrochloride and lidocaine hydrochloride through the PCA device.

Both medications are used to manage the pain caused by your vaso-occlusive crisis, which is a painful complication of sickle cell anemia that occurs when blood cells block blood vessels.

3 Pain level monitoring

Your pain levels will be regularly assessed using the VAS score, which stands for Visual Analog Scale. This is a simple tool where you indicate your pain level on a scale.

This monitoring will continue throughout your treatment period to track how well the pain medication is working.

4 Monitoring for side effects

You will be monitored for any adverse effects related to morphine. These are unwanted or harmful reactions that can occur when taking medication.

Any side effects you experience will be recorded and assessed by the medical team.

5 Blood sample collection

Blood samples will be collected at specific times during the study to measure certain biomarkers. Biomarkers are substances in your blood that can provide information about your condition and how your body is responding to treatment.

These samples will help assess changes in your condition over the course of the treatment.

6 Medication usage tracking

The total amount of morphine you use will be tracked throughout the study period.

This information is recorded automatically by the PCA device each time you use it to receive medication.

Who Can Join the Study?

  • You must be experiencing a vaso-occlusive crisis, which is a painful episode caused by blood vessels becoming blocked, and you need treatment with morphine PCA, which is a pain medicine pump that you control yourself
  • You must be 18 years of age or older

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial

Where you can join this trial?

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Other Sites

Site Name City Country Status
CHU Saint Pierre Brussels Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.12.2025

Trial locations

Morphine is a strong pain medication that belongs to a group of medicines called opioids. It works by blocking pain signals in the brain and spinal cord, helping to relieve severe pain. In this trial, morphine is given through a device called PCA (patient-controlled analgesia), which allows patients to control when they receive doses of the medication by pressing a button.

Lidocaine is a medication that works as a local anesthetic and can help reduce pain. It blocks nerve signals in the body to provide pain relief. In this trial, lidocaine is being tested in combination with morphine using the same PCA device to see if adding it to morphine treatment can help reduce the total amount of morphine needed to control pain.

Sickle Cell Anaemia – Sickle cell anaemia is a genetic blood disorder that affects the shape and function of red blood cells. In this condition, red blood cells become rigid and curved into a crescent or sickle shape instead of being round and flexible. These abnormally shaped cells can block blood flow through small vessels, causing episodes of pain and reduced oxygen delivery to tissues. The disease is inherited when a person receives the sickle cell gene from both parents. People with this condition may experience painful episodes called crises, which occur when sickled cells obstruct blood vessels. Over time, the blocked blood flow and reduced oxygen can cause damage to various organs in the body.

Trial ID:
2025-523777-41-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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