[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643339":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":18,"responsibleParty":29,"collaborators":10,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":10,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},{"fullName":5,"class":6},"Meir Medical Center","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Stability and sterility of intrathecal morphine",null,[12],"Diagnostic Test: Culturing and testing chemical stability",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"DIAGNOSTIC_TEST","Culturing and testing chemical stability",[9],[19],{"facility":5,"status":10,"city":20,"state":10,"zip":10,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":10},"Kfar Saba","Israel","IL",{"type":24,"coordinates":25},"Point",[26,27],34.90694,32.175,{"lat":27,"lon":26},{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","sara dichtwald","Dr","100643339","investigation-of-chemical-stability-and-sterility-of-morphine-in-intrathecal-pumps-for-long-term-pain-management-100643339",false,"NCT07641608","Investigation of Chemical Stability and Sterility of Morphine in Intrathecal Pumps for Long-Term Pain Management","Morphine in Intrathecal Pumps for Long-Term Pain Management","Inclusion Criteria: • Adult patients (age ≥ 18 years), Diagnosed with chronic pain and currently treated with an implantable intrathecal pump.\n\n* Receiving intrathecal Morphine (Rafa Laboratories, 20 mg\u002Fml; registration no. 106-25-28981-00).\n* Scheduled for a routine pump refill procedure at an interval of 3 to 6 months.\n\nExclusion Criteria:• Patients receiving polyanalgesic mixtures (admixtures of morphine with other drugs) in the intrathecal pump.\n\n* Evidence of active systemic infection or localized infection at the pump implantation site.\n* History of recent pump malfunction or refills occurring outside the standard 3 to 6-month window.\n* Inability to provide informed consent.\n* Pregnant patients.","ALL","18 Years","99 Years",{"count":44,"type":45},5,"ESTIMATED","OBSERVATIONAL","Intrathecal drug delivery systems (IDDS) are effective for managing chronic pain by delivering medications directly into the cerebrospinal fluid. Morphine, a primary opioid used in these systems, must remain chemically stable and sterile over prolonged periods to ensure patient safety and therapeutic efficacy . Previous studies have evaluated morphine stability in vitro under simulated conditions , indicating minimal degradation in saline over time . However, there is limited real-world data regarding the residual morphine in pump reservoirs after extended use . This study seeks to bridge this gap by analyzing morphine aspirated from intrathecal pumps during routine refills in a clinical setting, while comparing it to in vitro samples taken in the clinic .. Objectives Primary Objective: To determine the chemical stability of morphine in intrathecal pump reservoirs over a 3 to 6-month period of clinical use.\n\nSecondary Objective: To assess the sterility of residual morphine and evaluate any microbial contamination.",[49],"Rate of Positive Culture From Morphine Aspirate","NOT_YET_RECRUITING","2026-06-07",{"date":53,"type":54},"2026-06-11","ACTUAL",{"date":56,"type":45},"2027-01-01",{"date":58,"type":45},"2028-01-01",{"name":5,"class":6},1]