[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-refractory-chronic-cancer-related-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-refractory-chronic-cancer-related-pain":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Opioid-Refractory Chronic Cancer-Related Pain",[28,29,30,31,32,33,34,35,36,37,38],"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","NOT_YET_RECRUITING","2026-02-18",{"date":42,"type":43},"2026-02-20","ACTUAL",{"date":45,"type":20},"2026-03",{"date":47,"type":20},"2027-08",{"name":49,"class":50},"National and Kapodistrian University of Athens","OTHER"]