Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
In 2012, more than 14 million cases of cancer were diagnosed worldwide, with the forecast for
2025 exceeding 20 million. Pain is the most critical symptom that accompanies cancer. The
development of disease generates the need for oncological palliative care and adequacy of the
structure by Public Health Care System. In this context, this study aims to evaluate an
alternative to the treatment plans provided for in the Brazilian's Public Health Care System
table. The objective is to carry out a cost-effectiveness analysis of the epidural
administration of morphine and ropivacaine in patients with abdominal neoplasia, and pain
that is difficult to clinically control, which leads to an improvement in the quality of
life, functional conditions and survival of patients, and that reduces the cost to the
Brazilian's Public Health Care System. This is a randomized clinical trial. Patients will be
divided into two groups: control and intervention. The control group will receive oral
treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of
the Brazilian's Ministry of Health: morphine, pregabalin and duloxetine. The intervention
group will receive an anesthetic solution containing morphine and ropivacaine for epidural
administration through a surgically implanted catheter. Pain, quality of life, functional
capacity and survival will be evaluated using the following instruments: Visual Analogue
Scale; European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire "Core" 30; Karnofsky Performance Scale; Eastern Cooperative Oncology Group
Scale; Palliative Performance Scale; and Palliative Prognosis Index. It is expected that, at
the end of the study, the intervention group will represent a significant savings for the
Public Health Care System, due to the decrease in the number of hospitalizations/day and the
possible complications due to the lack of effectiveness of the oral treatment. It is expected
that the results found will produce scientific support to disseminate the proposed treatment
plan for Brazilian's Public Health Care System patients in palliative care.
Phase:
Phase 4
Details
Lead Sponsor:
Universidade Federal de Alfenas
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais