[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547208":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":33,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":33,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":33,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":33,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Ioannina","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid Free Anaesthesia (OFA group)","EXPERIMENTAL","Patients are randomly allocated to receive non-opioid anaesthesia. Intraoperative analgesia will be achieved by continuous intravenous administration of a mixture of dexmedetomidine, ketamine, and lidocaine.",[13],"Other: Opioid Free Anaesthesia (OFA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional general anaesthesia (CGA group)","ACTIVE_COMPARATOR","Patients are randomly allocated to receive conventional general anaesthesia with intraoperative use of opioids at the discretion of the attending anaesthesiologist.",[19],"Other: Conventional General Anaesthesia (CGA)",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Opioid Free Anaesthesia (OFA)","Patients are allocated to receive non-opioid anaesthesia intraoperatively. Patients will receive a mixture of dexmedetomidine, ketamine and lidocaine for intraoperative analgesia.",[9],[26],"N.O.A.M (non-opioid anaesthetic mixture: dexmedetomidine, ketamine and lidocaine)",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Conventional General Anaesthesia (CGA)","Patients are allocated to receive conventional general anaesthesia intraoperatively with the use of fentanyl and morphine for intraoperative analgesia.",[15],[32],"O.A.M. (Opioid Anaesthetic Mixtute: fentanyl, morphine)",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Agathi Karakosta","CONTACT","+306948066243","akarakosta@uoi.gr",{"name":41,"role":37,"phone":42,"phoneExt":33,"email":43},"Gloria-Evdoxia Izountouemoi","+306982799750","gloriaizou@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Hospital of Ioannina","RECRUITING","Ioannina","Epirus","455 00","Greece","GR",{"type":54,"coordinates":55},"Point",[56,57],20.85187,39.66341,{"lat":57,"lon":56},[60,61],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":33,"email":43},{"type":63,"investigatorFullName":36,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Assistant Professor of Anaesthesiology","100547208","opioid-free-anaesthesia-in-breast-cancer-surgery-100547208",false,"NCT06404983","Opioid-free Anaesthesia in Breast Cancer Surgery","A Comparative Evaluation of Opioid Free Anaesthesia Technique Versus the Conventional Technique in Oncological Breast Surgery","Inclusion Criteria:\n\n* adult patients\n* breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia\n\nExclusion Criteria:\n\n* under 18 years\n* patient refusal\n* opioid use (systemic or not) for any reason (e.g., chronic malignant pain)\n* language barrier (difficulty in communicating in Greek language)\n* allergy to the administered agents\n* severe arrhythmia or other serious cardiac disease\n* severe liver and kidney failure\n* dementia, psychiatric diseases, and\u002For preoperative cognitive impairment","FEMALE","18 Years","99 Years",{"count":76,"type":77},200,"ESTIMATED","INTERVENTIONAL",[80],"NA","Background:\n\nVarious analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders.\n\nThe goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy\u002Fmastectomy, with or without axillary lymph node excision).\n\nSecondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively.\n\nDuring the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate\u002Fdoctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded.\n\nIntraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded.\n\nThe investigators expect to recruit at least 100 participants per group.",[83,84,85,86,87,88],"Breast Cancer","Anesthesia","Pain, Postoperative","Pain, Chronic","Opioid Free Anaesthesia","Cancer Recurrence","2026-05-01",{"date":91,"type":92},"2026-05-06","ACTUAL",{"date":94,"type":92},"2022-12-28",{"date":96,"type":77},"2027-09-12",{"name":5,"class":6},1]