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Lidocaine for opioid sparing in vaso-occlusive crisis of Sickle Cell Disease
EU CTIS ID: 2024-518437-28-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- Prior inclusion in the study in the last 3 months
- Patients under guardianship, curatorship or under legal protection
- Prisoners or subjects who are involuntarily incarcerated
- 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.
- Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
See the full eligibility criteria
Who can join
- 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
What rules you out
- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- Prior inclusion in the study in the last 3 months
- Patients under guardianship, curatorship or under legal protection
- Prisoners or subjects who are involuntarily incarcerated
- 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.
- Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
- Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient
- 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)
- 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
- Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure
- 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 according to CKD-EPI
- Acute or Chronic kidney failure with clearance <30mL/min/m2
- Body weight <40kg and >120kg
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.