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.
調査の概要
状態
完了
詳細な説明
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)
研究の種類
介入
入学 (実際)
63
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Kim Lien
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Hà Nội、Kim Lien、ベトナム
- Department of Anesthesiology and Resuscitation, Bach Mai Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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
|
|
アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Intensity at Rest at 24 Hours
時間枠:At 24 hours postoperatively
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative Morphine Equivalent Consumption
時間枠: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
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From 0 to 24 hours postoperatively
|
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Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours
時間枠:At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
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Pain intensity scores assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during coughing at multiple scheduled postoperative time intervals
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At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
|
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Incidence of Postoperative Complications and Adverse Events
時間枠:Up to 72 hours postoperatively
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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)
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Up to 72 hours postoperatively
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Time to Gastrointestinal Recovery
時間枠: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)
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Up to 72 hours postoperatively
|
|
First Postoperative Night Sleep Quality
時間枠: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
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On the first postoperative night
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Postoperative Length of Hospital Stay
時間枠: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)
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協力者と研究者
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月15日
一次修了 (実際)
2026年8月15日
研究の完了 (実際)
2026年8月15日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-BMH-ĐT.RG-2026.12.Đ11
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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