Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
18 Years
N/A
Both
Advanced Cancer, Intractable Pain
Trial Information
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pain improvement between 2 groups.
Outcome Description:
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.
Outcome Time Frame:
At 3 month
Safety Issue:
No
Principal Investigator
Denis Dupoiron, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
ICO Paul Papin
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CPP-401
NCT ID:
NCT01567345
Start Date:
January 2009
Completion Date:
October 2010
Related Keywords:
- Advanced Cancer
- Intractable Pain
- Pain
- cancer
- Intrathecal
- analgesia
- Morphine
- Implantable pump
- Pain, Intractable
- Neoplasms
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