Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (PITAC)
|Advanced Cancer Intractable Pain||Device: Implantable pump with continuous flow Device: Implantable pump with programmable flow.||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.|
- Pain improvement between 2 groups. [ Time Frame: At 3 month ]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.
- Pain improvement with intrathecal analgesia compared to previous antalgic therapy. [ Time Frame: at 3 month ]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).
- Adverse Events assessment. [ Time Frame: every month ]
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.
- Patient's performance status improvement. [ Time Frame: At 1 month ]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.
- Incidence and types of complications. [ Time Frame: every month. ]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.
|Study Start Date:||January 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Intrathecal pump with continuous flow
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
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.
Other Name: Isomed Pump 8472
Experimental: Intrathecal pump with programmable flow.
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.
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.
Other Name: Synchromed II pump 8637
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567345
|ICO Paul Papin|
|Angers, France, 49933|
|Bordeaux, France, 33076|
|Laon, France, 02001|
|Centre Oscar Lambret|
|Lille, France, 53020|
|Nantes, France, 44093|
|Poitiers, France, 86000|
|Principal Investigator:||Denis Dupoiron, MD||ICO Paul Papin|