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RecruitingNCT07396558Updated Sep 17, 2026

Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain

An interventional study of Erector Spinae Plane Block in Cancer Pain and Erector Spinae Plane Block, sponsored by Hanoi Medical University. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Hanoi Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cancer Pain
  • Erector Spinae Plane Block

Keywords

  • Erector Spinae Plane Block
  • Regional Anesthesia
  • Cancer-Related Pain
  • Lung Cancer
  • Subcutaneous Port
  • Palliative Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • ProcedureErector 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.

05

What researchers measure

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 discharge

Secondary 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 discharge

  4. 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 discharge

06

Study locations

1 of 1 sites recruiting
  • Hanoi Medical University
    Hanoi, 100000, Vietnam
    Recruiting
07

References and documents

Publications

  • Fallon M, Giusti R, Aielli F, Hoskin P, Rolke R, Sharma M, Ripamonti CI; ESMO Guidelines Committee. Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv166-iv191. doi: 10.1093/annonc/mdy152. No abstract available. PubMed 30052758 ↗
  • Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19. PubMed 30886130 ↗
  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PubMed 27501016 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07396558
Lead sponsor
Hanoi Medical University
Responsible party
Sponsor
First posted
Feb 9, 2026
Start date
Mar 1, 2026
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Vu Hoang Phuong, MD, PhD
Contact
vuhoangphuong@hmu.edu.vn
+84912300978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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