Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection

NCT07642336 | Recruiting

• 1 other identifier: IRB-BMH-ĐT.RG-2026.12.Đ11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Neoplasms; Hepatic Resection; Liver Cancer

Keywords

Postoperative Pain; Acute Pain; Hepatic Resection

Outcome Measures

Primary Outcomes (1)

• 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

  At 24 hours postoperatively

Secondary Outcomes (6)

• Cumulative Morphine Equivalent Consumption

  From 0 to 24 hours postoperatively

• Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours

  At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively

• Incidence of Postoperative Complications and Adverse Events

  Up to 72 hours postoperatively

• Time to Gastrointestinal Recovery

  Up to 72 hours postoperatively

• First Postoperative Night Sleep Quality

  On the first postoperative night

Study Arms (2)

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

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

Procedure: Thoracic Epidural Analgesia (TEA)

Interventions

Thoracic Epidural Analgesia (TEA) PROCEDURE

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

Thoracic Epidural Analgesia Group

Continuous Erector Spinae Plane block PROCEDURE

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

Erector Spinae Plane Block Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Toan Thang: lead

Study Sites (1)

Department of Anesthesiology and Resuscitation, Bach Mai Hospital

Hà Nội, Kim Lien, Vietnam

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Pain, Postoperative; Acute Pain

Interventions

Tea

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, Anesthesiologist, Department of Anesthesia and Resuscitation

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: January 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)