Comparison of 2 morphine administration’s mode using Pump IntraThecal (IDDS)for Analgesia in patients with Cancer pain, resistant to conventional antalgic treatment - PITAC

• Conditions: Patients with intractable cancer pain, either uncontrolled with standard analgesia , or undergoing severe side effects due to analgesia .Patients undergo implantation of a Medtronic intrathecal pump and catheter system for delivery of morphine sulfate directly into the spinal fluid as well as clonidine and/or bupivacaine hydrochloride as adjuvants at the discretion of the investigating clinician. 2 way of morphine admisitration will be studied, continous drug flow and PCA.; MedDRA version: 9.1Level: LLTClassification code 10058019Term: Cancer pain; MedDRA version: 9.1Level: LLTClassification code 10059050Term: Intractable pain

• Registration Number: EUCTR2008-005087-14-FR
• Lead Sponsor: Centre Paul Papin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Advanced cancer patient
- Age = 18 years old
- Opioid-refractory pain with VAS pain level = 5
- either steady state levels of opioid or adjunctive pain medications, after a correct opioid change, modification of morphine way of administration, PCA with iv morphine,
- or severe side effects
- Has decision-making capacity
- Able to go back home
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient's refusal
- Pregnancy
- Systemic infection
- Spinal puncture's infection
- Life expectancy < 90 days
- Known hypersensitivity or intolerance to morphine
- Contra-indication of intrathecal catheter
- patient treated with potent CYP1a2 inhibitors such as fluvoxamine or enoxacine

Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified