[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624327":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":45,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"National and Kapodistrian University of Athens","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine and Ketamine Infusion","ACTIVE_COMPARATOR",null,[13],"Drug: Lidocaine and Ketamine Infusion",{"label":15,"type":16,"description":11,"interventionNames":17},"Active Placebo (Midazolam) Infusion","PLACEBO_COMPARATOR",[18],"Drug: Active Placebo (Midazolam) Infusion",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Participants receive two intravenous infusions, 7 days apart, containing lidocaine 4 mg\u002Fkg and ketamine 0.2 mg\u002Fkg (using actual body weight, or ideal body weight if BMI \\>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Participants receive two intravenous infusions, 7 days apart, containing midazolam 0.02mg\u002Fkg (using actual body weight, or ideal body weight if BMI \\>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.",[15],[28,31,33],{"name":29,"affiliation":5,"role":30},"Konstantinos Kalimeris, Assoc Prof of Anesthesiology","STUDY_CHAIR",{"name":32,"affiliation":5,"role":30},"Maria Riga, Assis Prof of Anesthesiology",{"name":34,"affiliation":5,"role":30},"Ioannis Kotsantis, Assis Prof of Oncology",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor","CONTACT","+302105831997","kkalimeris@med.uoa.gr",{"name":42,"role":38,"phone":43,"phoneExt":11,"email":44},"Erond Zeneli MD, PhD candidate","+306982094129","erond.zeneli@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University General Hospital of Athens \"Attikon\" - National and Kapodistrian University of Athens Medical School","RECRUITING","Athens","Attica","12461","Greece","GR",{"type":55,"coordinates":56},"Point",[57,58],23.72784,37.98376,{"lat":58,"lon":57},[61,63,65],{"name":62,"role":38,"phone":39,"phoneExt":11,"email":40},"Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology",{"name":64,"role":38,"phone":43,"phoneExt":11,"email":11},"Erond Zeneli, MD",{"name":64,"role":66,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Konstantinos Kalimeris","Associate Professor of Anesthesiology",[71],{"name":72,"class":6},"Attikon Hospital","100624327","early-phase-1-the-role-of-coadministration-of-lidocaine-and-ketamine-in-opioid-refractory-chronic-cancer-related-pain-100624327",false,"NCT07408193","The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.","The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain: a Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Trial.","Inclusion Criteria:\n\n* Age 18 years or more\n* Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures\n* Meets the IASP definition for chronic cancer-related pain\n* Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h\n* Adequate trial of opioid medication, defined as a dose of at least 60 mg\u002Fday oral morphine equivalent or maximum tolerated dose, in the past 24h\n* For patients with neuropathic component to pain: adequate trial of at least one adjuvant analgesic, defined as a daily dose of at least Amitriptyline 37.5mg, Duloxetine 30mg, Gabapentin 900mg, Pregabalin 150mg, Venlafaxine 60mg or equivalent (26), or maximum tolerated dose in the past 24h\n\nExclusion Criteria:\n\n* Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam\n* Severe liver disease (Child Class B or C)\n* SGPT or SGOT \\>5 times the upper limit of normal\n* End stage kidney disease\n* Serious cardiac comorbidity (e.g. unstable angina, poorly controlled hypertension or tachycardia, high-risk coronary vascular disease, symptomatic heart failure with NYHA class III-IV, history of heart block, Wolf-Parkinson-White syndrome, Adams-Stokes syndrome)\n* Elevated intracranial or intraocular pressure\n* Pheochromocytoma or poorly controlled hyperthyroidism\n* History of psychosis, schizophrenia or substance abuse\n* Pregnant or breastfeeding\n* Porphyria\n* Life expectancy shorter than the duration of the study","ALL","18 Years",{"count":83,"type":84},24,"ESTIMATED","INTERVENTIONAL",[87],"EARLY_PHASE1","This is a randomized, double-blinded, placebo-controlled, cross-over trial examining the effect of a series of two weekly intravenous infusions of lidocaine 4 mg\u002Fkg and ketamine 0.2 mg\u002Fkg in patients with moderate to severe opioid-refractory chronic cancer-related pain. The aim of this study is to investigate whether the lidocaine - ketamine (LK) regimen provides better analgesia that an active placebo of midazolam 0.02 mg\u002Fkg, in this population.",[90],"Opioid-Refractory Chronic Cancer-Related Pain",[92,93,94,95,96,97,98,99,100,101,102],"Cancer Pain","Treatment-Resistant Chronic Pain","Lidocaine","Ketamine","Analgesics, Adjuvant","Infusions, Intravenous","Cross-Over Studies","Double-Blind Method","Patient Reported Outcome Measures","Opioid-Related Disorders","Neoplasms","2026-07-05",{"date":105,"type":106},"2026-07-07","ACTUAL",{"date":108,"type":106},"2026-03-01",{"date":110,"type":84},"2027-08",{"name":5,"class":6},1]