Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Resection | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Erector Spinae Plane block | Procedure | — | UNRESOLVED |
| Thoracic Epidural Analgesia (TEA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Erector Spinae Plane Block Group
- description
- 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
- interventionNames
- Procedure: Continuous Erector Spinae Plane block
- type
- ACTIVE_COMPARATOR
- label
- Thoracic Epidural Analgesia Group
- description
- 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
- interventionNames
- Procedure: Thoracic Epidural Analgesia (TEA)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available