Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHanoi Medical University
About this trial
Cancer-related pain is a common and challenging problem in patients with lung cancer, often requiring long-term pain management. Conventional pain treatments, including systemic medications, may not provide adequate relief or may cause significant side effects.
The erector spinae plane (ESP) block is a regional anesthesia technique that can help reduce pain by delivering local anesthetic near the nerves supplying the chest wall. This study aims to evaluate the effectiveness and safety of intermittent ESP block administered through a subcutaneous port for controlling cancer-related pain in patients with lung cancer.
Eligible patients with lung cancer and moderate to severe pain will receive intermittent ESP block injections via a subcutaneous port as part of their pain management plan. Pain intensity, analgesic requirements, and potential side effects will be assessed over time.
The results of this study may help determine whether intermittent ESP block via a subcutaneous port is a useful and feasible option for improving pain control and quality of life in patients with lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients diagnosed with advanced-stage lung cancer who are currently receiving palliative care only.
Presence of chronic cancer-related chest pain lasting longer than 1 month, localized to the thoracic region due to chest wall invasion, pleural involvement, or bone metastases.
Performance status ≤ 3 according to the Eastern Cooperative Oncology Group (ECOG), allowing placement of a subcutaneous port and maintenance of local anesthetic administration.
Inadequate pain control with conventional analgesic therapies or clinical indication for the addition of regional analgesia.
Disqualifiers
Chest pain with radiation to the upper extremities, neck, or shoulder, suggestive of non-localized thoracic pain.
Severe hepatic or renal dysfunction, or severe heart failure (New York Heart Association class III-IV).
Local infection at the injection or port placement site, or uncontrolled systemic infection.
Severe cachexia or insufficient subcutaneous tissue that does not allow safe coverage of the subcutaneous port.
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane Block
Procedure/SurgeryIntermittent erector spinae plane block administered via a subcutaneous port, allowing repeated delivery of local anesthetic for the management of cancer-related pain in patients with lung cancer.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: ESP Block GroupExperimental treatment 1 intervention
Group B: Historical Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Pain Intensity Measured by Visual Analog Scale (VAS) at Home at 3 Months After Discharge
Pain intensity is assessed at rest and during movement using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. Assessments are performed at predefined home-based follow-up time points after hospital discharge. The primary outcome is the change in VAS pain score from hospital discharge to 3 months after discharge, reflecting the sustained effectiveness of intermittent erector spinae plane block in home-based palliative care. Outcomes in the intervention group will be compared with those of the historical control group.
Time frame
From hospital discharge to 3 months after dischargeSecondary outcomes
1
Change in Pain Intensity at Early Time Points After Intervention
Pain intensity at rest and during movement is assessed using the Visual Analog Scale (VAS) at baseline, 30 minutes after the intervention, and at the time of transfer to the ward to evaluate the early analgesic effect of the erector spinae plane block.
Time frame
From baseline (H0) to 30 minutes after intervention (H1) and at the time of transfer to the ward (H2)2
Pain Intensity Trajectory During Home-Based Follow-Up
At predefined home-based follow-up time points on days 1, 3, and 5; weeks 1, 2, and 3; and months 1, 2, and 3 after hospital discharge
Time frame
Pain intensity at rest and during movement is measured using the Visual Analog Scale (VAS) at predefined home-based follow-up time points up to 3 months after discharge to describe the trajectory of pain control during home-based palliative care.3
Morphine Consumption During Home-Based Palliative Care
The daily dose of opioid analgesics used for rescue pain management during home-based follow-up is recorded and converted to morphine-equivalent doses to evaluate changes in opioid requirements over time.
Time frame
At predefined home-based follow-up time points on days 1, 3, and 5; weeks 1, 2, and 3; and months 1, 2, and 3 after hospital discharge4
Procedure-Related and Treatment-Related Adverse Events
Procedure-related and treatment-related adverse events are recorded, including respiratory and hemodynamic changes after intervention, catheter-related complications, local anesthetic systemic toxicity, and opioid-related adverse effects.
Time frame
At predefined home-based follow-up time points on days 1, 3, and 5; weeks 1, 2, and 3; and months 1, 2, and 3 after hospital dischargeSponsors and contacts
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Source ClinicalTrials.gov