Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain

February 1, 2026 updated by: Hanoi Medical University

Efficacy of Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer-Related Pain in Patients With Lung Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Hanoi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP Block Group
Patients receive intermittent erector spinae plane block administered via a subcutaneous port as part of multimodal pain management for cancer-related pain.
Procedure: Erector Spinae Plane Block
Intermittent 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.
No Intervention: Historical Control Group
Historical control group consisting of patients with lung cancer who previously received standard pain management without erector spinae plane block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Measured by Visual Analog Scale (VAS) at Home at 3 Months After Discharge
Time Frame: From hospital discharge to 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.
From hospital discharge to 3 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity at Early Time Points After Intervention
Time Frame: From baseline (H0) to 30 minutes after intervention (H1) and at the time of transfer to the ward (H2)
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.
From baseline (H0) to 30 minutes after intervention (H1) and at the time of transfer to the ward (H2)
Pain Intensity Trajectory During Home-Based Follow-Up
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.
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
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.
Morphine Consumption During Home-Based Palliative Care
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 discharge
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.
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
Procedure-Related and Treatment-Related Adverse Events
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 discharge
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB_HMU2628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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