2024-518437-28-00RecruitingPhase 3
Lidocaine for opioid sparing in vaso-occlusive crisis of Sickle Cell Disease
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Sept 2026
Brief summary (registry, in English)
To determine whether adding lidocaine to standard of care in pain management during sever vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent (MME).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 3 Jul 2026
- Lead sponsor
- Centre Hospitalier Universitaire De Nantes
- Diseases
- Sickle cell disease
- EU CT number
- 2024-518437-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 104
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with sickle cell disease who are in intensive care with a painful crisis or acute chest syndrome and have recently started morphine or oxycodone by injection or drip.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Sickle cell disease (SS, SC, Sβ0 or Sβ+ type). In intensive care mainly because of a vaso-occlusive crisis (acute pain) and/or acute chest syndrome (breathing signs with a new lung shadow on imaging).
- Earlier treatment
- Morphine or oxycodone given by injection or drip, started less than 72 hours before joining.
- Biomarker or test result
- Sickle cell genotype SS, SC, Sβ0 or Sβ+.
Main reasons for not taking part
- Pregnant or breastfeeding women
- On a breathing machine through a tube, or acute respiratory distress syndrome
- Epilepsy, or Glasgow coma scale below 13
- Heart rhythm or conduction problems, or heart failure
- Severe liver or kidney failure, or body weight under 40 kg or over 120 kg
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior inclusion in the study in the last 3 months
- Patient already enrolled in a clinical drug study
- Patients treated with anti-arhythmic drugs known to induce torsade de pointe
- Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and/or 1A2 cytochrome isoenzymes (CYP1A2)
Other illness
- Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home
- Acute Respiratory Distress Syndrome according to The 2012 Berlin definition
- Acute or Chronic liver failure with MELD > 19
- Sickle cell disease acute complication other than vaso-occlusive crisis or acute chest syndrome as the main reason for admission : priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis.
- Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient
Lab values
- Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure
- Acute or Chronic kidney failure with clearance <30mL/min/m² according to CKD-EPI
Other
- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria
- Patient under invasive mechanical ventilation
- Epileptic patients
- Altered consciousness with Glasgow coma scale <13
- Hypovolemic shock or shock of other cause at screening for inclusion
- Body weight <40kg and >120kg
- Patients under guardianship, curatorship or under legal protection
- Prisoners or subjects who are involuntarily incarcerated
- Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
Who the study is looking for
- Age ≥18 years
- Known sickle cell disease with an SS, SC, Sβ0, or Sβ+ genotype
- Patient admitted to the intensive care unit for vaso-occlusive crisis and/or acute chest syndrome as the main reason for admission : Vaso-occlusive crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other cause / Acute chest syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality (crepitants and/or bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.
- Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion
- Patient or next of kin informed about the study and having consented to participation of the patient in the study. If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the intensive care unit physician, in compliance with French law
- French speaking
- Patient with health care insurance
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire De La Guadeloupe | Les Abymes | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Hopital de la Timone | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire d'Orléans | ORLEANS | France | Recruiting |
| Hopital Tenon | Paris Cedex 20 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| Centre Hospitalier Universitaire Rouen | Rouen | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux | Talence | France | Recruiting |
| IUCT-Oncopole | Toulouse Cedex 9 | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.