Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain

Hanoi Medical University

Status: Not yet enrolling

Conditions: Cancer Pain; Erector Spinae Plane Block

Treatments: Procedure: Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07396558

ESPB_HMU2628

Details and patient eligibility

About

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.

Full description

Cancer-related pain in patients with lung cancer is often multifactorial and may be difficult to control using conventional systemic analgesic therapies alone. Regional anesthesia techniques have increasingly been explored as adjunctive approaches to improve pain control while minimizing systemic opioid exposure.

The erector spinae plane (ESP) block is a fascial plane block in which local anesthetic is injected adjacent to the erector spinae muscle, allowing spread to the dorsal and ventral rami of spinal nerves. This technique has been reported to provide effective analgesia for thoracic and chest wall pain with a favorable safety profile.

In this study, patients with lung cancer experiencing moderate to severe cancer-related pain will receive intermittent ESP block administered through a subcutaneous port. The port system allows repeated administration of local anesthetic without the need for repeated needle insertion, potentially improving patient comfort and feasibility of long-term pain management.

Pain intensity will be assessed using standardized pain assessment tools at predefined time points. Additional outcomes include changes in analgesic medication requirements, patient-reported comfort, and the occurrence of procedure-related or treatment-related adverse events.

This study is designed to evaluate the feasibility, effectiveness, and safety of intermittent ESP block via a subcutaneous port as part of a multimodal pain management strategy in patients with lung cancer.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.
• Ability to understand the study procedures and provide written informed consent after receiving a full explanation of the intervention.

Exclusion Criteria:

• 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.

• Known allergy to amide-type local anesthetics or other contraindications to regional anesthesia.

• Severe cognitive impairment, altered consciousness, or inability to cooperate with post-intervention monitoring.

• Lack of adequate caregiver support for home-based follow-up after discharge or inability to coordinate follow-up with local healthcare facilities.

• Severe coagulation disorders, defined as:

  • International normalized ratio (INR) > 1.5
  • Activated partial thromboplastin time (aPTT) > 40 seconds
  • Fibrinogen < 1.5 g/L
  • Platelet count < 50 × 10⁹/L.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

ESP Block Group

Experimental group

Description:

Patients receive intermittent erector spinae plane block administered via a subcutaneous port as part of multimodal pain management for cancer-related pain.

Treatment:

Procedure: Erector Spinae Plane Block

Historical Control Group

No Intervention group

Description:

Historical control group consisting of patients with lung cancer who previously received standard pain management without erector spinae plane block.