Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 12
- 主要终点
- Pain improvement between 2 groups.
研究概览
简要总结
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
详细描述
Cancer is frequently associated with pain. In spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. Indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management.
Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps. Patients with advanced cancer are often treated at WHO step 3 analgesics, i.e. morphine and its derivatives, at high dosages. But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks.
At this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. In this study, we want to compare the quality of analgesia obtained through these 2 flows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years old.
- •Patient with advanced cancer.
- •Patient with severe pain, i.e. a mean daily pain score > or = 5 on an numeric rating scale.
- •Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
- •Possibility of return home
- •Dated and signed informed consent form.
排除标准
- •Patient's refusal to participate in the study.
- •Ongoing pregnancy.
- •Ongoing systemic infection.
- •Injection site infection.
- •Estimated survival less than 90 days.
- •Allergy or intolerance to morphine.
- •Contraindication to implantation of an intrathecal catheter.
- •Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
- •Intrathecal chemotherapy planned.
结局指标
主要结局
Pain improvement between 2 groups.
时间窗: At 3 month
Pain will be assessed every day by patient using a Visual Analog Scale (VAS. VAS scores will be compared between 2 groups(continuous or programmable flow). We want to demonstrate the superiority of intrathecal analgesia obtained through programmable flow compared to continuous flow.
次要结局
- Pain improvement with intrathecal analgesia compared to previous antalgic therapy.(at 3 month)
- Adverse Events assessment.(every month)
- Patient's performance status improvement.(At 1 month)
- Incidence and types of complications.(every month.)