Cancer PainNCT07396558
Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer Pain
A study testing Erector Spinae Plane Block in people with Cancer Pain and Erector Spinae Plane Block, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Erector Spinae Plane Block
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Medical University
Hanoi, 100000
Nguyen Huu Tu, Professor, +84912334335, nguyenhuutu@hmu.edu.vn
About this study
Official title: 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.
Read more
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.
- Conditions
- Cancer Pain, Erector Spinae Plane Block
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Regional Anesthesia, Cancer-Related Pain, Lung Cancer, Subcutaneous Port, Palliative Care
- Medical subject headings
- Cancer Pain, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital discharge to 3 months after discharge
Secondary outcomes (4)
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396558
- Sponsor's protocol ID
- ESPB_HMU2628
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30052758Kot 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 30886130Forero 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Erector Spinae Plane Block Via Subcutaneous Port for Cancer-Related Pain in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07396558
- Acronym / sponsor ID
- ESPB_HMU2628
- Conditions
- Cancer Pain, Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Regional Anesthesia, Cancer-Related Pain, Lung Cancer, Subcutaneous Port, Palliative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ESP Block Group | Experimental | Procedure: Erector Spinae Plane BlockPatients receive intermittent erector spinae plane block administered via a subcutaneous port as part of multimodal pain management for cancer-related pain. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockIntermittent 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. | Procedure or surgery | ESP Block Group |
Primary outcome
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.
4 secondary outcomes
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 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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 30052758Fallon 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.
- Background: PubMed 30886130Kot 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.
- Background: PubMed 27501016Forero 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.
- Individual participant dataSharing planned: No
Related trials for Cancer Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Cancer Pain and Erector Spinae Plane Block, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vu Hoang Phuong, MD, PhD (+84912300978, vuhoangphuong@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.