Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

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

Detailed Description
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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.

Official Title
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Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.

Conditions
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Advanced Cancer, Intractable Pain

Intervention / Treatment
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* Device: Implantable pump with continuous flow
* Device: Implantable pump with programmable flow.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal pump with continuous flow<br>After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it. | Device: Implantable pump with continuous flow<br>* 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.<br>* Other names: Isomed Pump 8472;|
| Experimental: Intrathecal pump with programmable flow.<br>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. | Device: Implantable pump with programmable flow.<br>* 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.<br>* Other names: Synchromed II pump 8637;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | every month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, cancer, Intrathecal, analgesia, Morphine, Implantable pump