Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

Institut Cancerologie de l'Ouest54 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer Intractable Pain

Interventions

Implantable pump with continuous flowDEVICE

Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled.

Implantable pump with programmable flow.DEVICE

Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

ICO Paul Papin

Angers, France

Institut Bergonié

Bordeaux, France

Centre Hospitalier

Laon, France

Centre Oscar Lambret

Lille, France

Hôpital Laennec

Outcomes

Primary Outcomes

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.

Time frame: At 3 month

Secondary Outcomes

Pain improvement with intrathecal analgesia compared to previous antalgic therapy.

Using Visual Analog Scale's score, we want to demonstrate the superiority of intrathecal analgesia compared to previous treatment (pain is assessed through VAS within 4 days before inclusion).

Time frame: at 3 month

Adverse Events assessment.

We want to demonstrate a reduction of adverse events related to intrathecal analgesia compared to the previous treatment and to compare the two delivery systems. Adverse events due to morphine (6 types) will be scored according to 4 levels, then the sum of these scores will constitute an adverse event severity index ranging from 0 to 18. This index will be compared between the 2 arms and will also be compared to baseline values before introduction of intrathecal analgesia.

Time frame: every month

Patient's performance status improvement.

We want to demonstrate improvement of the patient's performance status during intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.

Time frame: At 1 month

Incidence and types of complications.

We want to compare the incidence and type of complications (infectious, morphine-related and co-analgesic treatments-related, due to the intrathecal catheter, to the implantable pump) between the two delivery systems.

Time frame: every month.

Data from ClinicalTrials.gov

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