Lidocaine for opioid sparing in vaso-occlusive crisis of Sickle Cell Disease

Trial details

Who runs it

Centre Hospitalier Universitaire De Nantes

Trial code

EU 2024-518437-28-00

Record updated

2026. szeptember 3.

Original description

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).Read full original descriptionShow less

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).

Inclusion: 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.

Exclusion: 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); 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; 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; 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.

EU CTIS 2024-518437-28-00