[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472985":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":84,"collaborators":18,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":18,"enrollmentInfo":95,"targetDuration":18,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Institut Curie","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OFA group","EXPERIMENTAL","OFA (Opioid Free Anaesthesia) group:",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"CA control group","NO_INTERVENTION","CA (Conventional Anaesthesia) control group:",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Dexmedetomidine","Dexmedetomidine+Lidocaine",[9],[26],{"name":27,"affiliation":28,"role":29},"Mary SAAD, MD","Institut Curie Saint-Cloud","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Anne-Claire COYNE, PhD","CONTACT","0033156245765","anne-claire.coyne@curie.fr",{"name":27,"role":33,"phone":37,"phoneExt":18,"email":38},"0033147112371","mary.saad@curie.fr",[40,60,71],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Institut Curie Paris","RECRUITING","Paris","75005","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3488,48.85341,{"lat":51,"lon":50},[54,57],{"name":55,"role":33,"phone":18,"phoneExt":18,"email":56},"Jane Muret, MD","jane.muret@curie.fr",{"name":58,"role":59,"phone":18,"phoneExt":18,"email":18},"jane Muret, MD","PRINCIPAL_INVESTIGATOR",{"facility":28,"status":42,"city":61,"state":18,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Saint-Cloud","92210",{"type":48,"coordinates":64},[65,66],2.20289,48.84598,{"lat":66,"lon":65},[69,70],{"name":27,"role":33,"phone":18,"phoneExt":18,"email":38},{"name":27,"role":59,"phone":18,"phoneExt":18,"email":18},{"facility":72,"status":42,"city":73,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Gustave Roussy, Cancer Campus, Grand Paris","Villejuif",{"type":48,"coordinates":75},[76,77],2.35992,48.7939,{"lat":77,"lon":76},[80,83],{"name":81,"role":33,"phone":18,"phoneExt":18,"email":82},"Migena DEMIRI, MD","migena.demiri@gustaveroussy.fr",{"name":81,"role":59,"phone":18,"phoneExt":18,"email":18},{"type":85,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100472985","phase-3-opioid-free-versus-opioid-based-anaesthesia-for-free-flap-reconstruction-surgery-of-the-breast-a-phase-iii-multicentric-randomized-controlled-study-100472985",false,"NCT05439005","Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.","OFOBA","Inclusion Criteria:\n\n1. Women aged 18 or older.\n2. Patients with a French health insurance coverage (having a French social security number).\n3. Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.\n4. Patient who has given written consent to participate in accordance with the regulations.\n5. Having a negative blood pregnancy test for patients of childbea ring age.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).\n2. Known history of heart failure, arrhythmias and\u002For ischemic heart disease and\u002For severe renal insufficiency.\n3. Pulse below 50bpm during anaesthesia consultation and\u002For under beta blocker treatment.\n4. Treatment with ACEI\u002FARB.\n5. Severe asthma.\n6. Symptomatic gastric or duodenal ulcer with or without treatment.\n7. Baseline systolic blood pressure \\\u003C 100 mmHg.\n8. Chronic preoperative pain and\u002For use of WHO ladder step 2 or 3 analgesics preoperatively.\n9. Patient already included in another therapeutic trial evaluating an experimental molecule.\n10. Persons deprived of liberty or under guardianship.\n11. Patients with suspected difficulties in assessing pain on a scale.\n12. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.","FEMALE","18 Years",{"count":96,"type":97},158,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.",[103],"Breast Cancer",[105,106],"free flap reconstruction surgery","anaesthesia","2026-01-28",{"date":109,"type":110},"2026-01-30","ACTUAL",{"date":112,"type":110},"2022-12-07",{"date":114,"type":97},"2027-06-06",{"name":5,"class":6},3]