Clinical Trial

Investigation of Chemical Stability and Sterility of Morphine in Intrathecal Pumps for Long-Term Pain Management

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Summary
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. Secondary Objective: To assess the sterility of residual morphine and evaluate any microbial contamination.
Trial Details
NCT Number NCT07641608
Lead Sponsor Meir Medical Center
Conditions Rate of Positive Culture From Morphine Aspirate
Enrollment 5 participants
Start Date 2027-01-01
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-11