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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

2 criteria

  • 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 trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial
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Investigated drugs

  • 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.

What is already known about the treatment

  • Morphine

    Morphine is a strong pain medication that belongs to a group of medicines called opioids, which work by attaching to specific receptors in the brain and spinal cord to block pain signals from reaching the brain. In this clinical trial, it is given through a method called PCA (patient-controlled analgesia), where patients can control their own pain relief by pressing a button that delivers the medication directly into their bloodstream through an intravenous line. Morphine is widely used and approved in medical practice for treating severe pain, including the intense pain episodes called vaso-occlusive crises that occur in patients with sickle cell anemia. This study is comparing morphine used alone versus morphine combined with another medication called lidocaine to see which approach requires less total morphine to control pain effectively.

  • Lidocaine

    Lidocaine is a medication that blocks pain signals by temporarily stopping sodium channels in nerve cells from working, which prevents these nerves from sending pain messages to the brain. In this clinical trial, lidocaine is being tested in combination with morphine and delivered through the same PCA system, allowing patients to control when they receive the medication intravenously. While lidocaine is commonly used as a local anesthetic for numbing specific areas during medical procedures and is approved for certain types of chronic pain, its use in combination with morphine for sickle cell pain crises is still being studied. The goal is to determine if adding lidocaine to morphine can reduce the total amount of morphine needed to manage severe pain episodes in sickle cell anemia patients.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523777-41-01Estimated enrolment40 patientsSponsorCHU Saint Pierre

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).