[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614027":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":35,"locations":42,"responsibleParty":183,"collaborators":27,"id":185,"slug":27,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":27,"enrollmentInfo":193,"targetDuration":27,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":211,"whyStopped":27,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group: Lidocaine + standard of care","EXPERIMENTAL","Lidocaine hydrochloride 20 mg\u002FmL, solution, 20 mL ampoule for intravenous administration Administration : parenteral route on peripheral or central venous catheter.\n\n* Bolus of 1.5 mg\u002Fkg bolus during 30 minutes, with a maximum dose of 180 mg (18mL)\n* Immediately followed by a continuous infusion of 1 mg\u002Fkg\u002Fh (max 120mg\u002Fh =- 12mL\u002Fh) during 72 hours.",[13,14],"Drug: Lidocain","Drug: Standard of care",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group: placebo + standard of care","PLACEBO_COMPARATOR","Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection. Administration : parenteral route on peripheral or central venous catheter.\n\n* Bolus of 1.5 mg\u002Fkg bolus during 30 minutes, with a maxium dose of 180 mg (18mL)\n* Immediately followed by a continuous infusion of 1 mg\u002Fkg\u002Fh (max 120mg\u002Fh = 12mL\u002Fh) during 72 hours.",[20,14],"Drug: Placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Lidocain","Lidocaine hydrochloride 20 mg\u002FmL, solution, 20 mL ampoule for IV administration (25 ampoules) Administration : parenteral route on peripheral or central venous catheter. - Bolus of 1.5 mg\u002Fkg bolus dur",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo","Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection Administration : parenteral route on peripheral or central venous catheter.\n\n* Bolus of 1.5 mg\u002Fkg bolus during 30 minutes, with a maxium dose of 180 mg (18mL)\n* Immediately followed by a continuous infusion of 1 mg\u002Fkg\u002Fh (max 120mg\u002Fh = 12mL\u002Fh) during 72 hours.",[16],{"type":23,"name":33,"description":33,"armGroupLabels":34,"otherNames":27},"Standard of care",[16,9],[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Maïté AGBAKOU","CONTACT","02.44.76.80.54","+33","maite.agbakou@chu-nantes.fr",[43,59,72,80,91,104,117,130,143,156,169],{"facility":44,"status":27,"city":45,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHU Bordeaux","Bordeaux","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.58046,44.84124,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":57,"phoneExt":40,"email":58},"Arthur ORIEUX","05.56.79.56.79","arthur.orieux@chu-bordeaux.fr",{"facility":60,"status":27,"city":61,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"CHU Lille","Lille",{"type":49,"coordinates":63},[64,65],3.05512,50.63391,{"lat":65,"lon":64},[68],{"name":69,"role":38,"phone":70,"phoneExt":40,"email":71},"Arthur DURAND","03.20.44.40.84","arthur.durand@chu-lille.fr",{"facility":73,"status":27,"city":74,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":75,"geoPoint":79,"contacts":27},"CHU La Timone","Marseille",{"type":49,"coordinates":76},[77,78],5.38107,43.29695,{"lat":78,"lon":77},{"facility":81,"status":27,"city":82,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU de Nantes","Nantes",{"type":49,"coordinates":84},[85,86],-1.55336,47.21725,{"lat":86,"lon":85},[89],{"name":37,"role":38,"phone":90,"phoneExt":40,"email":41},"02.40.76.80.54",{"facility":92,"status":27,"city":93,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"CHU Orléans","Orléans",{"type":49,"coordinates":95},[96,97],1.90407,47.90248,{"lat":97,"lon":96},[100],{"name":101,"role":38,"phone":102,"phoneExt":40,"email":103},"Marie SKARZYNSKI","02.38.51.44.46","Marie.skarzynski@chu-orleans.fr",{"facility":105,"status":27,"city":106,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hôpital Tenon APHP","Paris",{"type":49,"coordinates":108},[109,110],2.3488,48.85341,{"lat":110,"lon":109},[113],{"name":114,"role":38,"phone":115,"phoneExt":40,"email":116},"Muriel FARTOUKH","01.56.01.61.32","muriel.fartoukh@aphp.fr",{"facility":118,"status":27,"city":119,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CHU Poitiers","Poitiers",{"type":49,"coordinates":121},[122,123],0.34348,46.58261,{"lat":123,"lon":122},[126],{"name":127,"role":38,"phone":128,"phoneExt":40,"email":129},"Delphine CHATELLIER","05.49.44.43.67","delphine.chatellier@chu-poitiers.fr",{"facility":131,"status":27,"city":132,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"CHU Rouen","Rouen",{"type":49,"coordinates":134},[135,136],1.09932,49.44313,{"lat":136,"lon":135},[139],{"name":140,"role":38,"phone":141,"phoneExt":40,"email":142},"Maximilien GRALL","02.32.88.58.28","maximilien.grall@chu-rouen.fr",{"facility":144,"status":27,"city":145,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Oncopole Toulouse","Toulouse",{"type":49,"coordinates":147},[148,149],1.44367,43.60426,{"lat":149,"lon":148},[152],{"name":153,"role":38,"phone":154,"phoneExt":40,"email":155},"Sihem BOUHARAOUA","05.31.15.61.14","Bouharaoua.sihem@iuct-oncopole.fr",{"facility":157,"status":27,"city":158,"state":27,"zip":27,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"CHRU Tours - Hôpital Bretonneau","Tours",{"type":49,"coordinates":160},[161,162],0.70398,47.39484,{"lat":162,"lon":161},[165],{"name":166,"role":38,"phone":167,"phoneExt":40,"email":168},"Charlotte SALMONGANDONNIERE","02.47.47.38.55","c.salmon-gandonniere@chu-tours.fr",{"facility":170,"status":27,"city":171,"state":27,"zip":27,"country":172,"countryCode":27,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"CHU Guadeloupe","Les Abymes","Guadeloupe",{"type":49,"coordinates":174},[175,176],-61.50507,16.273,{"lat":176,"lon":175},[179],{"name":180,"role":38,"phone":181,"phoneExt":27,"email":182},"Frédéric MARTINO","05.90.89.11.32","frederic.martino@chu-guadeloupe.fr",{"type":184,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100614027",false,"NCT07274254","Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease","LidoVOC","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype\n* Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and\u002For ACS as the main reason for admission:\n\n  * 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\u002For pelvis, not attributable to other causes\n  * Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and\u002For chest pain and\u002For auscultatory abnormality (crepitants and\u002For 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 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 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\n\nExclusion Criteria:\n\n* Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion\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:\n\npriapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…\n\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\u002For 1A2 cytochrome isoenzymes (CYP1A2)\n* Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria\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 \\\u003C30mL\u002Fmin\u002Fm2\n* Body weight \\\u003C40kg and \\>120kg\n* Prior inclusion in the study in the last 3 months\n* Patient under invasive mechanical ventilation\n* Altered consciousness with Glasgow coma scale \\\u003C13","ALL","18 Years",{"count":194,"type":195},104,"ESTIMATED","INTERVENTIONAL",[198],"PHASE3","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.",[201],"Vaso-Occlusive Pain Episode in Sickle Cell Disease",[203,204,205,206,207,208,209,210],"Sickle Cell disease","Sickle Cell Syndrome","Vaso-occlusive crisis","Acute Chest Syndrome","Painful crisis","Pain management","Opioid sparing","Lidocaine","NOT_YET_RECRUITING","2025-12-18",{"date":214,"type":215},"2025-12-26","ACTUAL",{"date":217,"type":195},"2026-03-01",{"date":219,"type":195},"2028-04-01",{"name":5,"class":6},11]