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: 9.1
Conditions
Interventions
Trade Name: Sulfate de Morphine
Product Name: Morphine
Pharmaceutical Form: Solution for infusion
CAS Number: 64313
Other descriptive name: MORPHINE SULFATE
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Centre Paul Papin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove that intrathecal morphine is more efficient with PCA than a continous drug delivery flow, in patients with intractable cancer pain.;Secondary Objective: To determine that intrathecal morphine is more efficient than prior analgesia with morphine using different way of administration To determine that intrathecal morphine is associated with less severe side effects than other way of morphine administration. To compare to modes of intrathecal morphine delivery (continous or PCA) To determine improvement of quality of life To compare the safety of different intrathecal morphine delivery modes;Primary end point(s): - Pain measurement on a 10 point numeric scale during the day, mean estimated rest pain and actvity pain once a day, catheter complications, morphine side effects, patient's ECOG, adjuvant treatment's side effects (ropivacaine, clonidine), total daily morphine dosage, antalgic consumption | — |
Countries
France
Outcome results
None listed