Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

NCT05558397 | Completed DMC

• 1 other identifier: 2.543.790
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of effectiveness of epidural morphine/ropivacaine treatment

  Change From Baseline in Pain Scores on the Visual Analog Scale (0 means no pain and 10 means worst pain) in patients in the control group and intervention group for up to 60 days.

  Up to 60 days

Secondary Outcomes (9)

• Assessment of quality of life

  Up to 60 days

• Assessment of functional status

  Up to 60 days

• Assessment of progression of disease status

  Up to 60 days

• Assessment of patient's clinical-functional status

  Up to 60 days

• Assessment of disease prognosis

  Up to 60 days

Study Arms (2)

Control Group (Oral Morphine)

ACTIVE COMPARATOR

The control group will be composed of 15 patients who will receive oral drug treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of the Brazilian Ministry of Health. The drugs included in the treatment plan are morphine (60 mg/day), pregabalin (150 mg/day) and duloxetine (60 mg/day), available free of charge to the participating patients. The treatment will be carried out orally in a home environment.

Drug: Control Group (Oral morphine)

Interventional Group (Epidural morphine)

EXPERIMENTAL

The intervention group will be composed of 15 patients who will undergo a surgical procedure for subcutaneous implantation of a catheter (Celsite ST304-19BBraun) that allows epidural administration of morphine and ropivacaine drugs. The treatment plan for such patients includes Patient Controlled Analgesia (PCA). Patients in this group will receive, via catheter, an anesthetic solution containing 2.0 mL of morphine (1.0 mg/mL), 3.0 mL of ropivacaine (7.5 mg/mL) and 5.0 mL of distilled water. For 24 hours after this application, if the patient continues to have pain, they may use a rescue dose of oral morphine of 10 mg.

Device: Interventional Group (Epidural morphine)

Interventions

Interventional Group (Epidural morphine) DEVICE

Implantation of an epidural catheter for administration of morphine and ropvacaine

Interventional Group (Epidural morphine)

Control Group (Oral morphine) DRUG

Oral administration of morphine, pregabalin or duloxetin

Control Group (Oral Morphine)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Patients with technical incapacity to implant the catheter will be excluded, namely: patient refusal, infection at the puncture site and hemodynamic instability.

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Larissa Helena Lobo Torres Pacheco

Alfenas, Minas Gerais, 37137001, Brazil

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Control Groups; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Larissa LT Pacheco, PhD

  Universidade Federal de Alfenas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Model Details: Control group: oral route morphine Intervention group: epidural route morphine

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 28, 2022
• Study Start: April 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

BR (1)