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

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.

Inclusion Criteria: • Adult patients (age ≥ 18 years), Diagnosed with chronic pain and currently treated with an implantable intrathecal pump.

• Receiving intrathecal Morphine (Rafa Laboratories, 20 mg/ml; registration no. 106-25-28981-00).
• Scheduled for a routine pump refill procedure at an interval of 3 to 6 months.

Exclusion Criteria:• Patients receiving polyanalgesic mixtures (admixtures of morphine with other drugs) in the intrathecal pump.

• Evidence of active systemic infection or localized infection at the pump implantation site.
• History of recent pump malfunction or refills occurring outside the standard 3 to 6-month window.
• Inability to provide informed consent.
• Pregnant patients.