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

2026年8月17日 更新者:Nguyen Toan Thang

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.

研究概览

详细说明

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%: 20 mL every 3 hours on the right side and 20 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 0.2% 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)

研究类型

介入性

注册 (实际的)

63

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kim Lien
      • Hà Nội、Kim Lien、越南
        • Department of Anesthesiology and Resuscitation, Bach Mai Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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
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
有源比较器: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
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative Pain Intensity at Rest at 24 Hours
大体时间:At 24 hours postoperatively
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

次要结果测量

结果测量
措施说明
大体时间
Cumulative Morphine Equivalent Consumption
大体时间:From 0 to 24 hours postoperatively
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
大体时间:At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
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
大体时间:Up to 72 hours postoperatively
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
大体时间:Up to 72 hours postoperatively
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
大体时间:On the first postoperative night
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
大体时间:From the day of surgery to hospital discharge (estimated up to 14 days)
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月15日

初级完成 (实际的)

2026年8月15日

研究完成 (实际的)

2026年8月15日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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