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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07641608

Enrollment

Registered

2026-06-11

Start date

2027-01-01

Completion date

2028-01-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rate of Positive Culture From Morphine Aspirate

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.

Interventions

DIAGNOSTIC_TESTCulturing and testing chemical stability

Culturing and testing chemical stability

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of positive bacterial culture	1 week	Rate of positive bacterial culture from morphine aspirate

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026