Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
OBJECTIVES:
Primary
- Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA)
of bone metastases.
Secondary
- Assess minimum and average pain and analyze use of morphine sulfate before and after
RFA.
- Determine disease progression by CT scan of bone.
- Evaluate the percentage of relief associated with RFA, specifically patient
satisfaction, quality of life, anxiety, depression, and physical performance during
RFA.
- Assess complications and side effects related to RFA and the evolution of possible side
effects associated with morphine sulfate therapy.
OUTLINE: This is a multicenter study.
Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation
(RFA). Patients also complete questionnaires about pain, physical performance, quality of
life (QOL), and anxiety at baseline.
Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients
receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine
sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum
pain less than or equal to that at inclusion receive standard morphine sulfate therapy
instead.
Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain
intensity; side effects and complications of RFA; and total dose of morphine sulfate (or
equivalent) is collected daily.
Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires
about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at
12 weeks.
Interventional
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Maximum pain level decreased by ≥ 2 points at 8 weeks after radiofrequency ablation (RFA)
No
Florence Dixmerias, MD
Study Chair
Institut Bergonié
Unspecified
CDR0000589594
NCT00712712
October 2007
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