Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

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.

Conditions

• Cancer Pain
• Opioid Use
• Cost Analysis
• Palliative Care
• Epidural Route
• Morphine-ropivacaine Association
• Quality of Life
• Rational Use of Medication

Interventions

DEVICE

Interventional Group (Epidural morphine)

Implantation of an epidural catheter for administration of morphine and ropvacaine

DRUG

Control Group (Oral morphine)

Oral administration of morphine, pregabalin or duloxetin

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do estado de Minas Gerais

  collaborator OTHER

• Universidade Federal de Alfenas

  lead OTHER

Principal Investigators

• Larissa LT Pacheco, PhD · Universidade Federal de Alfenas

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2022-12-31

Completion

2023-12-31

Countries

• Brazil

Study Locations