Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

NCT01567345 | Completed DMC

• 2 other identifiers: CPP-4012008-005087-14
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Advanced Cancer; Intractable Pain

Keywords

Pain; cancer; Intrathecal; analgesia; Morphine; Implantable pump

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain improvement with intrathecal analgesia compared to previous antalgic therapy.

  at 3 month

• Adverse Events assessment.

  every month

• Patient's performance status improvement.

  At 1 month

• Incidence and types of complications.

  every month.

Study Arms (2)

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.

Device: Implantable pump with continuous flow

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.

Device: Implantable pump with programmable flow.

Interventions

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.

Also known as: Isomed Pump 8472

Intrathecal pump with continuous flow

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.

Also known as: Synchromed II pump 8637

Intrathecal pump with programmable flow.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (6)

ICO Paul Papin

Angers, 49933, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Hospitalier

Laon, 02001, France

Location

Centre Oscar Lambret

Lille, 53020, France

Location

Hôpital Laennec

Nantes, 44093, France

Location

Polyclinique

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Pain, Intractable; Pain; Neoplasms; Agnosia

Interventions

Infusion Pumps, Implantable

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Denis Dupoiron, MD

  Institut Cancerologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 30, 2012
• Study Start: January 14, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (6)