Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

Not Applicable

Completed

• Conditions: Advanced Cancer; Intractable Pain
• Interventions: Device: Implantable pump with continuous flow; Device: Implantable pump with programmable flow.

• Registration Number: NCT01567345
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Study Timeline

• Study Start: 2009-01-14
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal pump with continuous flow	Implantable pump with continuous flow	After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.
Intrathecal pump with programmable flow.	Implantable 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.

Primary Outcome Measures

Name	Time	Method
Pain improvement between 2 groups.	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 Outcome Measures

Name	Time	Method
Pain improvement with intrathecal analgesia compared to previous antalgic therapy.	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.	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.	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.	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.

Trial Locations

Locations (6)

ICO Paul Papin; 🇫🇷 Angers, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hôpital Laennec; 🇫🇷 Nantes, France

Polyclinique; 🇫🇷 Poitiers, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Hospitalier; 🇫🇷 Laon, France