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

June 7, 2026 updated by: sara dichtwald, Meir Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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..

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stability and sterility of intrathecal morphine
Diagnostic test: Culturing and testing chemical stability
Culturing and testing chemical stability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of positive bacterial culture
Time Frame: 1 week
Rate of positive bacterial culture from morphine aspirate
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MMC-0224-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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