Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection (NCT07642336) | Clinical Trial Compass
RecruitingNot Applicable
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
Vietnam60 participantsStarted 2026-06-15
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two pain control methods after open liver surgery — an erector spinae plane block versus a thoracic epidural — so can you explain how each of these works and which one you currently use for patients like me?
2Since this study is listed as 'Phase NA,' meaning it's comparing two existing techniques rather than testing a brand-new drug, what does that mean for what's already known about the safety of both approaches?
3The trial's main goal is measuring pain levels at rest 24 hours after surgery — can you tell me how pain management in the first day after open liver resection might affect my overall recovery, and whether either technique has advantages beyond that 24-hour window?
4Would being in this trial mean I'm randomly assigned to one pain method without a choice, and if so, are there risks specific to either the epidural or the nerve block that I should weigh before deciding whether to participate?
5If I choose not to join this trial, what pain control approach would you recommend for my open liver surgery, and would that differ from what's being studied here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.