[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643339":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":23,"overallOfficials":13,"centralContacts":13,"locations":28,"responsibleParty":39,"collaborators":13,"id":43,"slug":13,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":13,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":13,"studyType":55,"phases":13,"briefSummary":56,"conditions":57,"keywords":13,"overallStatus":59,"whyStopped":13,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Meir Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of positive bacterial culture","Rate of positive bacterial culture from morphine aspirate","1 week",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Adult patients (age ≥ 18 years), Diagnosed with chronic pain and currently treated with an implantable intrathecal pump, receiving intrathecal Morphine (Rafa Laboratories, 20 mg\u002Fml; registration no. 106-25-28981-00), scheduled for a routine pump refill procedure at an interval of 3 to 6 months..",[19],{"label":20,"type":13,"description":13,"interventionNames":21},"Stability and sterility of intrathecal morphine",[22],"Diagnostic Test: Culturing and testing chemical stability",[24],{"type":25,"name":26,"description":26,"armGroupLabels":27,"otherNames":13},"DIAGNOSTIC_TEST","Culturing and testing chemical stability",[20],[29],{"facility":5,"status":13,"city":30,"state":13,"zip":13,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":13},"Kfar Saba","Israel","IL",{"type":34,"coordinates":35},"Point",[36,37],34.90694,32.175,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","sara dichtwald","Dr","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":53,"type":54},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.",[58],"Rate of Positive Culture From Morphine Aspirate","NOT_YET_RECRUITING","2026-06-07",{"date":62,"type":63},"2026-06-11","ACTUAL",{"date":65,"type":54},"2027-01-01",{"date":67,"type":54},"2028-01-01",{"name":5,"class":6},1]