Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (PITAC)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Advanced Cancer; Intractable Pain

Treatments: Device: Implantable pump with continuous flow; Device: Implantable pump with programmable flow.

Study type: Interventional

Funder types: Other

Identifiers

NCT01567345

2008-005087-14 (EudraCT Number)

CPP-401

Details and patient eligibility

About

The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Intrathecal pump with continuous flow

Active Comparator group

Description:

After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.

Treatment:

Device: Implantable pump with continuous flow

Intrathecal pump with programmable flow.

Experimental group

Description:

After placement of the implantable pump, programmable flow is scheduled by physician and patient can do himself morphine bolus injections for a better control of acute episodes of pain.

Treatment:

Device: Implantable pump with programmable flow.