Clinical trial NCT05558397: Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment
Official title: Effectiveness of Epidural Morphine and Ropivacaine Treatment for Abdominal Cancer Pain in Patients of Brazilian's Public Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Opioid Use
Cost Analysis
Palliative Care
Epidural Route
Morphine-ropivacaine Association
Quality of Life
Rational Use of Medication
Lead sponsor: Universidade Federal de Alfenas
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2022-09-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: oral route morphine Intervention group: epidural route morphine
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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.

Primary outcomes:
measure: Assessment of effectiveness of epidural morphine/ropivacaine treatment
timeFrame: Up to 60 days
Secondary outcomes:
measure: Assessment of quality of life
timeFrame: Up to 60 days
measure: Assessment of functional status
timeFrame: Up to 60 days
measure: Assessment of progression of disease status
timeFrame: Up to 60 days
measure: Assessment of patient's clinical-functional status
timeFrame: Up to 60 days
measure: Assessment of disease prognosis
timeFrame: Up to 60 days
measure: Cost-effectiveness analysis
timeFrame: Up to 60 days
measure: Quantify the plasma concentration of morphine
timeFrame: Up to 60 days
measure: Correlating plasma morphine concentration with therapeutic effecs
timeFrame: Up to 60 days
measure: Quantify brain-derived neurotrophic factor (BDNF)
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Alfenas
country: Brazil
facility: Larissa Helena Lobo Torres Pacheco
state: Minas Gerais
Study officials:
affiliation: Universidade Federal de Alfenas
name: Larissa LT Pacheco, PhD
role: STUDY_DIRECTOR
References: