Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain improvement between 2 groups.
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.
At 3 month
Denis Dupoiron, MD
ICO Paul Papin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)