Investigation of Chemical Stability and Sterility of Morphine in Intrathecal Pumps for Long-Term Pain Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Culturing and testing chemical stability.
- Who it may be relevant to
- Registry conditions: Rate of Positive Culture From Morphine Aspirate. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Morphine in Intrathecal Pumps for Long-Term Pain Management
Overview
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.
Interventions
- Diagnostic test Culturing and testing chemical stability
Culturing and testing chemical stability
Primary outcome measures
- Rate of positive bacterial culture [Time frame: 1 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT07641608 · MMC-0224-26