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
1 other identifier
observational
5
1 country
1
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2027
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
Study Completion
Last participant's last visit for all outcomes
January 1, 2028
June 11, 2026
June 1, 2026
1 year
June 1, 2026
June 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of positive bacterial culture
Rate of positive bacterial culture from morphine aspirate
1 week
Study Arms (1)
Stability and sterility of intrathecal morphine
Interventions
Culturing and testing chemical stability
Eligibility 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..
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 11, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
June 11, 2026
Record last verified: 2026-06