Morphine in Intrathecal Pumps for Long-Term Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.