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Recruiting NCT07642336

NCT07642336 Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection

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Clinical Trial Summary
NCT ID NCT07642336
Status Recruiting
Phase
Sponsor Nguyen Toan Thang
Condition Liver Neoplasms
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2026-06-15
Primary Completion 2026-08-15

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Continuous Erector Spinae Plane blockThoracic Epidural Analgesia (TEA)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2026-06-15 with a primary completion date of 2026-08-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Frequently Asked Questions

Who can join the NCT07642336 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07642336 currently recruiting?

Yes, NCT07642336 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nguyen Toan Thang to inquire about joining.

Where is the NCT07642336 trial being conducted?

This trial is being conducted at Hà Nội, Vietnam.

Who is sponsoring the NCT07642336 clinical trial?

NCT07642336 is sponsored by Nguyen Toan Thang. The trial plans to enroll 60 participants.

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