Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain

NCT07396558 | Not Yet Recruiting DMC

• 1 other identifier: ESPB_HMU2628
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Pain; Erector Spinae Plane Block

Keywords

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

Outcome Measures

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.

  From hospital discharge to 3 months after discharge

Secondary Outcomes (4)

• Change in Pain Intensity at Early Time Points After Intervention

  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

  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

  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

  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

Study Arms (2)

ESP Block Group

EXPERIMENTAL

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

Historical Control Group

NO INTERVENTION

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

Interventions

Erector Spinae Plane Block PROCEDURE

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.

ESP Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 30052758 BACKGROUND

• 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.

  PMID: 30886130 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Cancer Pain; Lung Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Vu Hoang Phuong, MD, PhD

CONTACT

+84912300978; vuhoangphuong@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment design including an intervention group receiving intermittent erector spinae plane block via a subcutaneous port and a historical control group consisting of patients who received standard pain management prior to the implementation of the intervention. Outcomes are compared between the intervention group and the historical control group.

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)