Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

NCT ID: NCT01567345

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-14
• Study Completion Date: 2010-10-31

Brief Summary

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

Conditions

Advanced Cancer; Intractable Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intrathecal pump with continuous flow

After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.

Group Type: ACTIVE_COMPARATOR

Implantable pump with continuous flow

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Implantable pump with programmable flow.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Isomed Pump 8472; Synchromed II pump 8637

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Dupoiron, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Cancerologie de l'Ouest

Locations

ICO Paul Papin

Angers, , France

Institut Bergonié

Bordeaux, , France

Centre Hospitalier

Laon, , France

Centre Oscar Lambret

Lille, , France

Hôpital Laennec

Nantes, , France

Polyclinique

Poitiers, , France

Countries

France

Other Identifiers

2008-005087-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CPP-401

Identifier Type: -

Identifier Source: org_study_id