[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tramadol-adverse-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tramadol-adverse-effect":25},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100655268","prospective-pharmacogenetic-cohort-study-of-cyp2d6-metabolizer-phenotype-analgesic-failure-and-adverse-effects-in-postoperative-patients-receiving-tramadol-by-elastomeric-infusion-pump-100655268",false,"NCT07810816","Prospective Pharmacogenetic Cohort Study of CYP2D6 Metabolizer Phenotype, Analgesic Failure, and Adverse Effects in Postoperative Patients Receiving Tramadol by Elastomeric Infusion Pump","Inclusion Criteria:\n\n* Elective surgery followed by the institution's standardized tramadol-containing elastomeric analgesia pump.\n* Ability to report pain on a 0-to-10 numeric rating scale.\n* Provision of a blood or buccal sample for CYP2D6 genotyping before or immediately after surgery.\n* Written informed consent for genetic testing, storage of genotype data, and clinical follow-up.\n\nExclusion Criteria:\n\n* Known tramadol allergy or contraindication.\n* Chronic opioid therapy, opioid use disorder, or opioid tolerance requiring an individualized regimen.\n* Severe renal or hepatic dysfunction outside the standardized pump eligibility criteria.\n* Concomitant medication or condition that requires deviation from the standard pump before the first outcome assessment.\n* Pregnancy or breastfeeding.\n* Inability to provide reliable pain scores or complete 72-hour monitoring.","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","1 Month","OBSERVATIONAL","This prospective pharmacogenetic cohort will enroll postoperative patients receiving a standardized tramadol-containing elastomeric analgesia pump. CYP2D6 genotype will be measured but will not determine treatment during the 72-hour study window. Participants with non-normal metabolizer phenotypes will be compared with normal metabolizers for analgesic treatment failure and adverse effects. Pain, rescue medication, pump discontinuation, sedation, respiratory status, nausea\u002Fvomiting, and other adverse events will be assessed at prespecified times.",[24,25,26],"Acute Postoperative Pain","Tramadol Adverse Effect","Pharmacogenetic Variation",[28,29,30,31,32,33],"CYP2D6","Tramadol","Pharmacogenetics","Analgesic Failure","Adverse Drug Reaction","Postoperative Pain","RECRUITING","2026-09-03",{"date":37,"type":38},"2026-09-09","ACTUAL",{"date":40,"type":38},"2023-01-12",{"date":42,"type":19},"2026-12-01",{"name":44,"class":45},"Research Inc","INDUSTRY"]