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

NCT07641608 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

  • Rate of Positive Culture From Morphine Aspirate

Interventions

DIAGNOSTIC_TEST

Culturing and testing chemical stability

Culturing and testing chemical stability

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641608 on ClinicalTrials.gov