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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Intractable Pain
• Intervention / Treatment: Device: Implantable pump with continuous flow; Device: Implantable pump with programmable flow.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • ICO Paul Papin
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Laon, France, 02001
    • Centre Hospitalier
  • Lille, France, 53020
    • Centre OSCAR LAMBRET
  • Nantes, France, 44093
    • Hôpital Laënnec
  • Poitiers, France, 86000
    • Polyclinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Synchromed II pump 8637

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Denis Dupoiron, MD, Institut Cancerologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2009
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (ESTIMATE): March 30, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pain; cancer; Morphine; analgesia; Intrathecal; Implantable pump
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable
• Other Study ID Numbers: CPP-401; 2008-005087-14 (EUDRACT_NUMBER)