Treatment of Cancer Pain Using an Implantable Intrathecal Pump
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
This study evaluates the effectiveness and safety of an implantable intrathecal pump for the treatment of cancer-related pain compared with standard subcutaneous analgesic infusion. Cancer-related pain can be difficult to control with systemic opioid therapy and is often associated with significant side effects and reduced quality of life.
Implantable intrathecal pumps allow direct delivery of analgesic medication into the intrathecal space, enabling effective pain control with lower drug doses and fewer systemic adverse effects. The study compares pain intensity, symptom burden, medication requirements, and quality of life in patients receiving analgesia via an implantable intrathecal pump versus those treated with a subcutaneous pump.
The results of this study aim to support the introduction of implantable intrathecal pumps into routine clinical practice for selected patients with refractory cancer pain.
详细描述
This prospective interventional clinical study investigates the use of an implantable intrathecal pump for the management of refractory cancer-related pain. Patients with advanced malignant disease and insufficient pain control despite optimized systemic opioid therapy are included.
Participants are assigned to one of two treatment approaches: implantation of an intrathecal pump for continuous intrathecal delivery of analgesic medication, or standard care using a subcutaneous infusion pump delivering equipotent analgesic doses. Analgesic regimens are adjusted according to clinical response and patient needs.
Pain intensity is assessed using validated pain scales, and symptom burden is monitored regularly. Quality of life is evaluated using standardized questionnaires at baseline and during follow-up. Additional outcomes include opioid consumption, adverse events, and patient satisfaction with pain management.
The study is conducted at a single tertiary oncology center and follows ethical principles outlined in the Declaration of Helsinki. All participants provide written informed consent prior to enrollment. Findings from this study are intended to inform clinical decision-making and support the integration of implantable intrathecal pumps into standard oncological pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignant disease.
- •Age between 40 and 80 years.
- •Cancer-related pain with intensity ≥ 5 on the Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) despite optimized conventional analgesic therapy.
- •Daily opioid requirement equivalent to ≥ 200 mg oral morphine, or inability to tolerate systemic opioid therapy due to adverse effects.
- •Expected life expectancy of at least 6 months.
- •Physical condition allowing implantation of an intrathecal pump or use of a subcutaneous infusion pump.
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Refusal or inability to provide informed consent.
- •Severe cardiac disease (NYHA class > III).
- •Severe chronic obstructive pulmonary disease (FEV1 < 40%).
- •Presence of significant neurological disease.
- •Presence of severe psychiatric disorder.
- •Regular use of psychotropic medications that could interfere with pain assessment.
- •Age younger than 40 years or older than 80 years.
研究组 & 干预措施
Intrathecal Pump Group
Implantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain.
干预措施: Implantable Intrathecal Pump (Device)
Subcutaneous Pump Group
Subcutaneous infusion pump used for continuous analgesic medication delivery.
干预措施: Subcutaneous Analgesic Pump (Device)
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline and 4 weeks after initiation of analgesic therapy
Change in pain intensity assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain), including assessment of average and maximum pain.
次要结局
未报告次要终点