Cancer PainNCT05558397
Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment
A study testing Interventional Group (Epidural morphine) in people with Cancer Pain and Opioid Use, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Pain, Opioid Use, Cost Analysis
- What is being tested?
- Interventional Group (Epidural morphine)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with technical incapacity to implant the catheter will be excluded, namely: patient refusal, infection at the puncture site and hemodynamic instability.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Larissa Helena Lobo Torres Pacheco
Alfenas, Minas Gerais, 37137001
About this study
Official title: Effectiveness of Epidural Morphine and Ropivacaine Treatment for Abdominal Cancer Pain in Patients of Brazilian's Public Health System
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
- Being tested
- Interventional Group (Epidural morphine), Control Group (Oral morphine)
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Group (Epidural morphine)Device
Implantation of an epidural catheter for administration of morphine and ropvacaine
Control Group (Oral morphine)Drug
Oral administration of morphine, pregabalin or duloxetin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Interventional Group (Epidural morphine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 days
Secondary outcomes (9)
Assessment of quality of life
Change of quality of life score by the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30), which consists of a likert-type scale ranging from 1 to 4 for functions and symptoms, where 1= not at all, 2=slightly, 3= moderately, and 4 = very much. If the resulting score on the functional scale is high, this represents a healthy functional level, while a high score on the symptom scale represents a low level of symptom tolerance and treatment side effects. This scale also assesses overall health, ranging from 1 to 7, with 1=bad and 7 = very good
Measured: Up to 60 days
Assessment of functional status
Change in the patient's functional status by the Karnofsky Performance Scale (KPS), which ranges from 100% to 0%, where 100% means no evidence of disease and 0% means death
Measured: Up to 60 days
Assessment of progression of disease status
Change in disease status using the Eastern Cooperative Oncology Group (ECOG) scale, ranging from 0 to 5, where 0 = completely active and 5 =dead
Measured: Up to 60 days
Assessment of patient's clinical-functional status
Change in clinical-functional status by the Palliative Performance Scale (PPS), which ranges from 100 to 0%, where 100% = good clinical-functional status and 0%= dead
Measured: Up to 60 days
Assessment of disease prognosis
Change in survival time by the Palliative Prognosis Scale (PPI), which assesses PPS, presence of delirium, dyspnea, oral intake and edema, where each factor presents a score and at the end the scores are summed and the patient is classified into group A (Total Score < 2.0): > 6 weeks survival, group B (Total Score between 2.0 - 4.0): 3 - 6 weeks survival and group C (Total Score > 4.0): < 3 weeks survival
Measured: Up to 60 days
Cost-effectiveness analysis
For cost-effectiveness analysis, a direct cost analysis using the cost-effectiveness ratio will be used. The costs considered in this study will be the direct non-medical and direct medical costs. For direct cost analysis, the microcosting technique will be used.
For economic analysis, the incremental cost-effectiveness ratio (ICER) will be used. Once a CERI is obtained, the result is evaluated by defining a cost-effectiveness threshold, which aims to identify values that society considers feasible, from an economic point of view, to be incorporated as additional costs in society's spending on health (BRASIL, 2014).
Once the RCEI is obtained, the next step in a pharmacoeconomic analysis will be to perform a sensitivity analysis of the parameters involved during the research.
Measured: Up to 60 days
Quantify the plasma concentration of morphine
Patients will undergo blood draws to obtain plasma, 1:30h after taking morphine (oral or epidural) which will later be quantified for morphine by gas chromatography.
Measured: Up to 60 days
Correlating plasma morphine concentration with therapeutic effecs
The amount of morphine found in plasma (outcome 8) will be correlated with the therapeutic effects (pain levels by Visual Analog Scale)
Measured: Up to 60 days
Quantify brain-derived neurotrophic factor (BDNF)
BDNF quantification will be done in the plasma of the patients, using the BDNF enzyme-linked immunosorbent assay (ELISA) kit from sigma and adverse effects
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Apr 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: oral route morphine Intervention group: epidural route morphine
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Larissa Helena Lobo Torres Pacheco, Universidade Federal de Alfenas
- Investigators
- Larissa LT Pacheco, PhD, Study director, Universidade Federal de Alfenas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558397
- Sponsor's protocol ID
- 2.543.790
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Epidural Morphine and Ropivacaine Treatment for Abdominal Cancer Pain in Patients of Brazilian's Public Health System
- ClinicalTrials.gov ID
- NCT05558397
- Acronym / sponsor ID
- 2.543.790
- Conditions
- Cancer Pain, Opioid Use, Cost Analysis, Palliative Care, Epidural Route, Morphine-ropivacaine Association
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: oral route morphine Intervention group: epidural route morphine
| Arm | Type | Receives |
|---|---|---|
| Control Group (Oral Morphine) | Active comparator | Drug: 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. |
| Interventional Group (Epidural morphine) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with technical incapacity to implant the catheter will be excluded, namely: patient refusal, infection at the puncture site and hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional Group (Epidural morphine)Implantation of an epidural catheter for administration of morphine and ropvacaine | Device | Interventional Group (Epidural morphine) |
| Control Group (Oral morphine)Oral administration of morphine, pregabalin or duloxetin | Drug | Control Group (Oral Morphine) |
Primary outcome
Assessment of effectiveness of epidural morphine/ropivacaine treatment
Time frame: Up to 60 days
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.
9 secondary outcomes
Assessment of quality of life
Time frame: Up to 60 days
Assessment of functional status
Time frame: Up to 60 days
Assessment of progression of disease status
Time frame: Up to 60 days
Assessment of patient's clinical-functional status
Time frame: Up to 60 days
Assessment of disease prognosis
Time frame: Up to 60 days
Cost-effectiveness analysis
Time frame: Up to 60 days
Quantify the plasma concentration of morphine
Time frame: Up to 60 days
Correlating plasma morphine concentration with therapeutic effecs
Time frame: Up to 60 days
Quantify brain-derived neurotrophic factor (BDNF)
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Related trials for Cancer Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa LT Pacheco, PhD study director
Universidade Federal de Alfenas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Group (Epidural morphine) in people with Cancer Pain and Opioid Use, run by Universidade Federal de Alfenas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of effectiveness of epidural morphine/ropivacaine treatment (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.