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New treatment option for Vaso-Occlusive Pain Episode in Sickle Cell Disease
Official title Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease
ClinicalTrials.gov ID: NCT07274254
What this study is testing
What is Lidocain?
Lidocain is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vaso-occlusive pain episode in sickle cell disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to determine whether adding lidocaine to standard of care in pain management during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years
- Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
- Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS 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)...
- Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality...
You likely can't join if
- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- Patients under guardianship, curatorship or under legal protection
- Prisoners or people 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...
- 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
See the full eligibility criteria
- Age \>= 18 years
- Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
- Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS 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 causes
- 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...
- 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 the 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...
- French speaking
- Patient with health care insurance
- Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- Patients under guardianship, curatorship or under legal protection
- Prisoners or people 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...
- 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
- Epileptic patients
- 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 \ 120kg
- Prior inclusion in the study in the last 3 months
- Patient under invasive mechanical ventilation
- Altered consciousness with Glasgow coma scale \<13
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lille, France
- Marseille, France
- Nantes, France
- Orléans, France
- Paris, France
- Poitiers, France
- Rouen, France
- Toulouse, France
- Tours, France
- Les Abymes, Guadeloupe
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lille, France; Marseille, France; Nantes, France; Orléans, France; Paris, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.