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Completed

NCT Number: NCT01567345

Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICO Paul Papin, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Isomed Pump 8472

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.

Other names: Synchromed II pump 8637

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: PITAC

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2012
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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