Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

NCT ID: NCT05558397

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group (Oral Morphine)

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.

Group Type: ACTIVE_COMPARATOR

Control Group (Oral morphine)

Intervention Type: DRUG

Oral administration of morphine, pregabalin or duloxetin

Interventional Group (Epidural morphine)

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.

Group Type: EXPERIMENTAL

Interventional Group (Epidural morphine)

Intervention Type: DEVICE

Implantation of an epidural catheter for administration of morphine and ropvacaine

Interventions

Interventional Group (Epidural morphine)

Implantation of an epidural catheter for administration of morphine and ropvacaine

Intervention Type: DEVICE

Control Group (Oral morphine)

Oral administration of morphine, pregabalin or duloxetin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Universidade Federal de Alfenas

OTHER

Sponsor Role: lead

Responsible Party

Larissa Helena Lobo Torres Pacheco

PhD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larissa LT Pacheco, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Alfenas

Locations

Larissa Helena Lobo Torres Pacheco

Alfenas, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

2.543.790

Identifier Type: -

Identifier Source: org_study_id