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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Neoplasms; Liver Cancer; Hepatic Resection
• Intervention / Treatment: Procedure: Continuous Erector Spinae Plane block; Procedure: Thoracic Epidural Analgesia (TEA)

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%: 24 mL every 3 hours on the right side and 12 mL every 3 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 0.1% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 5-8 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Kim Lien
    • Hà Nội, Kim Lien, Vietnam
      • Recruiting
      • Department of Anesthesiology and Resuscitation, Bach Mai Hospital
      • Contact: thanh Nguyen, MD; Phone Number: +84936137328; Email: ndthanhhmu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane Block Group; 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; 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
Active Comparator: Thoracic Epidural Analgesia Group; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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)	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	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	From the day of surgery to hospital discharge (estimated up to 14 days)

Collaborators and Investigators

• Sponsor: Nguyen Toan Thang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Acute Pain; Hepatic Resection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain; Liver Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Plant Preparations; Biological Products; Complex Mixtures; Tea
• Other Study ID Numbers: IRB-BMH-ĐT.RG-2026.12.Đ11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No