ClinicalTrials.gg
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

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.

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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

In context

Cancer Pain

310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.

This study's planned enrollment of 180 is above the median of 62 across 235 interventional studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Performance status ≤ 3 according to the (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 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 ( 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 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:

    • (INR) > 1.5
    • Activated partial thromboplastin time (aPTT) > 40 seconds
    • Fibrinogen \< 1.5 g/L
    • count \< 50 × 10⁹/L.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.

Of 72 non-industry interventional studies with no phase under Cancer Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 18 months is close to that.

Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2026
First posted
Feb 9, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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