Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age >= 18 years
Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
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 X-ray, thoracic CT-scan, or lung ultrasound.
Disqualifiers
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 subjects who are involuntarily incarcerated
Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
Trial design
Treatments tested in this trial
- Lidocain
- Placebo
- Standard of care
Treatment groups
104 Participants
are divided into 2 treatment groupsLocations
11France
CHU Bordeaux Bordeaux France
CHU Lille Lille France
CHU La Timone Marseille France
CHU de Nantes Nantes France
Sponsors and collaborators
Nantes University Hospital
Lead sponsor
Source ClinicalTrials.gov