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Trial Title:
Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment
NCT ID:
NCT05558397
Condition:
Cancer Pain
Opioid Use
Cost Analysis
Palliative Care
Epidural Route
Morphine-ropivacaine Association
Quality of Life
Rational Use of Medication
Conditions: Official terms:
Cancer Pain
Morphine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Control group: oral route morphine Intervention group: epidural route morphine
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Interventional Group (Epidural morphine)
Description:
Implantation of an epidural catheter for administration of morphine and ropvacaine
Arm group label:
Interventional Group (Epidural morphine)
Intervention type:
Drug
Intervention name:
Control Group (Oral morphine)
Description:
Oral administration of morphine, pregabalin or duloxetin
Arm group label:
Control Group (Oral Morphine)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged between 18 and 75 years,
- both sexes
- diagnosed with abdominal neoplasia and with PPI < 2.0, which indicates a survival of
at least 90 days
- have full cognitive conditions
- Patients must also have a caregiver with cognitive conditions.
Exclusion Criteria:
- Patients with technical incapacity to implant the catheter will be excluded, namely:
patient refusal, infection at the puncture site and hemodynamic instability.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Larissa Helena Lobo Torres Pacheco
Address:
City:
Alfenas
Zip:
37137001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Larissa Helena LT Pacheco, PhD
Phone:
+55 (35) 988013379
Email:
larissa.torres@unifal-mg.edu.br
Investigator:
Last name:
Carlos Marcelo Barros, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Márcia Helena MC Podestá, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Liliana B Vieira, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Carla S Ceron, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Vanessa B Boralli, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Carolina Aparecida F Almeida, MSC
Email:
Sub-Investigator
Investigator:
Last name:
Rafaela F Rodrigues, PhD
Email:
Sub-Investigator
Start date:
April 1, 2018
Completion date:
August 2023
Lead sponsor:
Agency:
Universidade Federal de Alfenas
Agency class:
Other
Collaborator:
Agency:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Agency class:
Other
Source:
Universidade Federal de Alfenas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558397
