Clinical trial · Interventional
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.
NCT01567345CI-TRIAL-00079423PITACcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Intractable Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantable pump with continuous flow | Device | — | UNRESOLVED |
| Implantable pump with programmable flow. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intrathecal pump with continuous flow
- description
- After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.
- interventionNames
- Device: Implantable pump with continuous flow
- type
- EXPERIMENTAL
- label
- Intrathecal pump with programmable flow.
- description
- 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.
- interventionNames
- Device: Implantable pump with programmable flow.
Primary outcomes (1)
- measure
- Pain improvement between 2 groups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.