Investigation of Chemical Stability and Sterility of Morphine in Intrathecal Pumps for Long-Term … (NCT07641608) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigation of Chemical Stability and Sterility of Morphine in Intrathecal Pumps for Long-Term Pain Management
Israel5 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.