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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005087-14 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal pump with continuous flow | Active Comparator | After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it. |
|
| Intrathecal pump with programmable flow. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable pump with continuous flow | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis Dupoiron, MD | Institut Cancerologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Paul Papin | Angers | 49933 | France | |||
| Institut Bergonié |
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|
| 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. |
|
|
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. |
| Bordeaux |
| 33076 |
| France |
| Centre Hospitalier | Laon | 02001 | France |
| Centre Oscar Lambret | Lille | 53020 | France |
| Hôpital Laennec | Nantes | 44093 | France |
| Polyclinique | Poitiers | 86000 | France |
| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D010146 | Pain |
| D009369 | Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015918 | Infusion Pumps, Implantable |
| ID | Term |
|---|---|
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
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