LIDOCAINE HYDROCHLORIDE for Sickle cell disease

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Known sickle cell disease with an SS, SC, Sβ0, or Sβ+ genotype\n- 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.\n- Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion\n- 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\n- French speaking\n- Patient with health care insurance"}

Exclusion criteria

• {"criterion_text":"- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion\n- Epileptic patients\n- Hypovolemic shock or shock of other cause at screening for inclusion\n- Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure\n- Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home\n- Acute Respiratory Distress Syndrome according to The 2012 Berlin definition\n- Acute or Chronic liver failure with MELD > 19 according to CKD-EPI\n- Acute or Chronic kidney failure with clearance <30mL/min/m2\n- Body weight <40kg and >120kg\n- Prior inclusion in the study in the last 3 months\n- Patients under guardianship, curatorship or under legal protection\n- Prisoners or subjects who are involuntarily incarcerated\n- 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.\n- Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion\n- Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient\n- Patients treated with anti-arhythmic drugs known to induce torsade de pointe\n- Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and/or 1A2 cytochrome isoenzymes (CYP1A2)\n- Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria\n- Patient under invasive mechanical ventilation\n- Altered consciousness with Glasgow coma scale <13"}

Primary endpoints

• {"endpoint_text":"- Cumulative parenteral opioid dose between randomisation and discharge from the intensive care unit expressed in morphine milligram equivalent. Only parenteral morphine and parenteral oxycodone will be taken in account, as tramadol and codein are weak opioids, and stronger opioids like fentanyl or sufentanyl are not likely to be used for spontaneously breathing patients.","definition_or_measurement_approach":"Measured as cumulative parenteral opioid dose between randomisation and ICU discharge, expressed in morphine milligram equivalents (only parenteral morphine and parenteral oxycodone counted)."}

Secondary endpoints

• {"endpoint_text":"- Intensive care unit length of stay, in days, from randomisation\n- Hospital length of stay, in days, from randomisation\n- Visual Analogue pain Scale score and Categorical Pain Score score during intensive care unit stay\n- Time from randomisation to vaso-occlusive crisis resolution, defined as presence of at least three of the following four criteria: continuous apyrexia for the last 8 hours, no need for intravenous opioid infusion for the last 8 hours, ability to walk or move without pain, and absence of spontaneous pain with a Categorical Pain Scale ≤1\n- Time from randomisation to the last parenteral opioid dose\n- Frequency of vaso-occlusive crisis complications: a) secondary acute chest syndrome (i.e. acute chest syndrome occurring after randomisation), b) need for blood transfusion, c) need for red blood cell exchange, d) need for life-supporting therapies defined as invasive mechanical ventilation or dialysis or vasopressor support\n- Score of French version of Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at D28\n- Frequency of any adverse events and frequency of serious adverse events at D28\n- Frequency of re-admissions in hospital (medicine ward or intensive care unit) or emergency-room visits by D28\n- Incremental cost-effectiveness ratio (cost par Quality-Adjusted Life-Year, QALY) comparing lidocaine + standard of care to standard of care alone","definition_or_measurement_approach":"ICU and hospital length of stay measured in days from randomisation; pain measured using Visual Analogue Scale (VAS) and Categorical Pain Score during ICU stay; vaso-occlusive crisis resolution defined by ≥3 of: continuous apyrexia for last 8 hours, no IV opioid infusion for last 8 hours, ability to walk/move without pain, absence of spontaneous pain with CPS ≤1; time to last parenteral opioid dose measured from randomisation; complications recorded as specified (secondary ACS, transfusion, RBC exchange, need for life-supporting therapies); ASCQ-Me score at Day 28; adverse events and serious adverse events frequency at Day 28; readmissions/ER visits by Day 28; incremental cost-effectiveness ratio calculated as cost per QALY comparing lidocaine + SOC vs SOC alone."}

Methods

• Recruitment of eligible patients admitted to intensive care units at participating hospitals in France; enrolment performed in the ICU setting with patients or next of kin provided with study information and asked to consent; if patient is not competent and no next of kin can be contacted during screening, emergency inclusion can be completed by the ICU physician in compliance with French law.

France

Earliest CTIS Part Ii Submission Date

03-09-2025

Latest Decision Or Authorization Date

05-11-2025

Processing Time Days

63

Number Of Sites

11

Number Of Participants

104

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France