Liver NeoplasmsNCT07642336
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
A study testing Continuous Erector Spinae Plane block and Thoracic Epidural Analgesia (TEA) in people with Liver Neoplasms and Hepatic Resection, run by Nguyen Toan Thang at 1 site in Vietnam.
Trial summary
Background: Open liver resection is associated with severe postoperative pain. While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasms, Hepatic Resection, Liver Cancer
- What is being tested?
- Continuous Erector Spinae Plane block and Thoracic Epidural Analgesia (TEA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jun 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * Patients aged between 18 and 80 years old.
- American Society of Anesthesiologists (ASA) physical status classification I to III.
- Scheduled to undergo elective open liver resection (open hepatectomy).
- Patient provides written informed consent to participate in the study.
Who cannot join
- Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio [INR] > 1.5 or 2.0, or Platelet count [PLT] < 50 G/L or 100 G/L).
- Severe hepatic impairment (Child-Pugh Class C).
- Severe chronic obstructive pulmonary disease (COPD GOLD stage III-IV).
- Severe cardiac dysfunction with an ejection fraction (EF) < 35%.
- Severe obesity with a Body Mass Index (BMI) > 40 kg/m².
- Localized infection at the planned puncture/needle insertion site.
- Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine) or opioids (e.g., Morphine).
- Pregnancy or current lactation.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Anesthesiology and Resuscitation, Bach Mai Hospital
Hà Nội, Kim Lien
About this study
Official title: Comparison of Postoperative Analgesic Efficacy Between Erector Spinae Plane Block and Thoracic Epidural Analgesia in Open Hepatectomy: A Randomized Controlled Trial
Background: Open liver resection is associated with severe postoperative pain. While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma. Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications. Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection. Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.
Read the detailed description
This is a randomized, controlled, parallel-group, non-inferiority clinical trial conducted at Bach Mai Hospital. Eligible patients scheduled for elective open liver resection will be randomly allocated into one of two groups at a 1:1 ratio: 1. ESPB Group (n = 30): Patients will receive bilateral erector spinae plane catheters placed at the T7 level under ultrasound guidance prior to anesthesia induction. A bolus of 20 mL Ropivacaine 0.2% will be administered on each side. Postoperative analgesia will be maintained for 72 hours using a Programmed Intermittent Bolus (PIB) regimen of Ropivacaine 0.1%: 20 mL every 6 hours on the right side and 20 mL every 6 hours on the left side. 2. TEA Group (n = 30): Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace. An initial bolus of 10 mL Ropivacaine 0.2% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 6 mL/h for 72 hours. Multimodal Analgesia: All patients in both groups will receive a standardized general anesthesia protocol and systemic multimodal analgesia, including intravenous paracetamol (1 g every 6 hours) and nefopam (20 mg every 6 hours). Outcomes Evaluation: The primary outcome is the postoperative pain intensity measured by the Numerical Rating Scale (NRS) at rest 24 hours after surgery. Secondary outcomes include NRS pain scores at rest and during coughing at multiple time points up to 72 hours, cumulative 24-hour morphine consumption, hemodynamic parameters, and incidence of adverse events (e.g., hypotension, postoperative nausea and vomiting, hematoma, or catheter failure)
- Conditions
- Liver Neoplasms, Hepatic Resection, Liver Cancer
- Being tested
- Continuous Erector Spinae Plane block, Thoracic Epidural Analgesia (TEA)
- Keywords
- Postoperative Pain, Acute Pain, Hepatic Resection
- Medical subject headings
- Liver Neoplasms, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Erector Spinae Plane blockProcedure or surgery
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
Thoracic Epidural Analgesia (TEA)Procedure or surgery
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia Receives: Procedure: Continuous Erector Spinae Plane block |
| Thoracic Epidural Analgesia Group | Active comparator | Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia Receives: Procedure: Thoracic Epidural Analgesia (TEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity at Rest at 24 Hours
Postoperative pain intensity evaluated using the Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The score will be recorded at rest exactly 24 hours after the completion of the surgery
Measured: At 24 hours postoperatively
Secondary outcomes (6)
Cumulative Morphine Equivalent Consumption
The total amount of intravenous morphine equivalents (in milligrams) administered as rescue analgesia to the patient during the first 24 hours after surgery
Measured: From 0 to 24 hours postoperatively
Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours
Pain intensity scores assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during coughing at multiple scheduled postoperative time intervals
Measured: At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
Incidence of Postoperative Complications and Adverse Events
The percentage of patients experiencing technique-related complications (such as local hematoma, catheter dislodgement, block failure) or opioid-related side effects (including postoperative nausea and vomiting, pruritus, urinary retention), as well as pulmonary complications (atelectasis, pneumonia) and hemodynamic instability (hypotension, bradycardia)
Measured: Up to 72 hours postoperatively
Time to Gastrointestinal Recovery
Evaluation of bowel function recovery, measured by the time (in hours) from the end of surgery to the first passage of flatus (first anal exhaust), and the time (in hours) to the first tolerance of oral intake (solid or liquid food)
Measured: Up to 72 hours postoperatively
First Postoperative Night Sleep Quality
The patient's subjective sleep quality during the first night after surgery, evaluated using a visual analog scale (VAS for sleep) or the Pittsburgh Sleep Quality Index (PSQI) subscale, where sleep disruption and total sleep duration are assessed
Measured: On the first postoperative night
Postoperative Length of Hospital Stay
The total number of days from the completion of the surgical procedure to the day the patient is officially discharged from the hospital, meeting predefined standard discharge criteria
Measured: From the day of surgery to hospital discharge (estimated up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start15 Jun 2026
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Toan Thang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen Toan Thang, Bach Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642336
- Sponsor's protocol ID
- IRB-BMH-ĐT.RG-2026.12.Đ11
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual patient data will not be shared publicly to maintain patient confidentiality and privacy in accordance with local institutional regulations. The aggregated results will be published in the final thesis and scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy Between Erector Spinae Plane Block and Thoracic Epidural Analgesia in Open Hepatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07642336
- Acronym / sponsor ID
- IRB-BMH-ĐT.RG-2026.12.Đ11
- Conditions
- Liver Neoplasms, Hepatic Resection, Liver Cancer
- Keywords
- Postoperative Pain, Acute Pain, Hepatic Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nguyen Toan ThangUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 11 Jun 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.
Background: Open liver resection is associated with severe postoperative pain. While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma. Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications. Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection. Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.
Detailed description
This is a randomized, controlled, parallel-group, non-inferiority clinical trial conducted at Bach Mai Hospital. Eligible patients scheduled for elective open liver resection will be randomly allocated into one of two groups at a 1:1 ratio: 1. ESPB Group (n = 30): Patients will receive bilateral erector spinae plane catheters placed at the T7 level under ultrasound guidance prior to anesthesia induction. A bolus of 20 mL Ropivacaine 0.2% will be administered on each side. Postoperative analgesia will be maintained for 72 hours using a Programmed Intermittent Bolus (PIB) regimen of Ropivacaine 0.1%: 20 mL every 6 hours on the right side and 20 mL every 6 hours on the left side. 2. TEA Group (n = 30): Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace. An initial bolus of 10 mL Ropivacaine 0.2% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 6 mL/h for 72 hours. Multimodal Analgesia: All patients in both groups will receive a standardized general anesthesia protocol and systemic multimodal analgesia, including intravenous paracetamol (1 g every 6 hours) and nefopam (20 mg every 6 hours). Outcomes Evaluation: The primary outcome is the postoperative pain intensity measured by the Numerical Rating Scale (NRS) at rest 24 hours after surgery. Secondary outcomes include NRS pain scores at rest and during coughing at multiple time points up to 72 hours, cumulative 24-hour morphine consumption, hemodynamic parameters, and incidence of adverse events (e.g., hypotension, postoperative nausea and vomiting, hematoma, or catheter failure)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Procedure: Continuous Erector Spinae Plane blockPatients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia |
| Thoracic Epidural Analgesia Group | Active comparator | Procedure: Thoracic Epidural Analgesia (TEA)Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- * Patients aged between 18 and 80 years old.
Key exclusion criteria (8 listed)
- Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio [INR] > 1.5 or 2.0, or Platelet count [PLT] < 50 G/L or 100 G/L).
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 |
|---|---|---|
| Continuous Erector Spinae Plane blockPatients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia | Procedure or surgery | Erector Spinae Plane Block Group |
| Thoracic Epidural Analgesia (TEA)Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia | Procedure or surgery | Thoracic Epidural Analgesia Group |
Primary outcome
Postoperative Pain Intensity at Rest at 24 Hours
Time frame: At 24 hours postoperatively
Postoperative pain intensity evaluated using the Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The score will be recorded at rest exactly 24 hours after the completion of the surgery
6 secondary outcomes
Cumulative Morphine Equivalent Consumption
Time frame: From 0 to 24 hours postoperatively
Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours
Time frame: At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
Incidence of Postoperative Complications and Adverse Events
Time frame: Up to 72 hours postoperatively
Time to Gastrointestinal Recovery
Time frame: Up to 72 hours postoperatively
First Postoperative Night Sleep Quality
Time frame: On the first postoperative night
Postoperative Length of Hospital Stay
Time frame: From the day of surgery to hospital discharge (estimated up to 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. The individual patient data will not be shared publicly to maintain patient confidentiality and privacy in accordance with local institutional regulations. The aggregated results will be published in the final thesis and scientific journals
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Erector Spinae Plane block and Thoracic Epidural Analgesia (TEA) in people with Liver Neoplasms and Hepatic Resection, run by Nguyen Toan Thang 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity at Rest at 24 Hours (time frame: At 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.