Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNguyen Toan Thang
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* 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.
Disqualifiers
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%.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Erector Spinae Plane block
Procedure/SurgeryPatients 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/SurgeryPatients 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane Block GroupActive comparator 1 intervention
Group B: Thoracic Epidural Analgesia GroupActive comparator 1 intervention
Trial outcomes
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
Time frame
At 24 hours postoperativelySecondary outcomes
1
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
Time frame
From 0 to 24 hours postoperatively2
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
Time frame
At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively3
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)
Time frame
Up to 72 hours postoperatively4
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)
Time frame
Up to 72 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nguyen Toan Thang
Lead sponsor
Bach Mai Hospital
Sponsor institution
Source ClinicalTrials.gov