Thoracic Epidural Block for Severe Acute Pancreatitis (TEB-SAP)
Thoracic Epidural Block in Patients With Severe Acute Pancreatitis: A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Trial
Severe acute pancreatitis is a serious illness that can cause severe abdominal pain, inflammation, increased abdominal pressure, feeding intolerance, and early problems with breathing, circulation, and kidney function. Patients with severe acute pancreatitis often need treatment in the intensive care unit. Pain control is an important part of treatment, but conventional pain medicines, especially opioids, may cause side effects such as respiratory depression, reduced bowel movement, nausea, vomiting, delirium, and delayed enteral nutrition.
Thoracic epidural block is a regional pain-control technique. It may relieve abdominal pain by blocking pain signals and sympathetic nerve activity from the chest and upper abdominal region. This treatment may also reduce the need for systemic opioid medicines, improve bowel function, improve tolerance to enteral nutrition, and reduce the need for early organ support in some patients.
This study is a single-center, prospective, randomized, open-label, parallel-group trial. Adult patients with severe acute pancreatitis will be randomly assigned to either a thoracic epidural block group or a conventional analgesia group. Patients in the thoracic epidural block group will receive continuous thoracic epidural infusion of ropivacaine alone, without epidural opioids such as sufentanil, fentanyl, or morphine. Intravenous pain medicines will be used only before epidural block initiation, as rescue analgesia when epidural pain control is inadequate, or after epidural block is paused, fails, or is discontinued. Patients in the conventional analgesia group will receive standard pain treatment according to clinical practice.
The main goal of this study is to determine whether thoracic epidural block can increase the number of days patients are alive and free from ICU-level organ support during the first 14 days after randomization. ICU-level organ support includes invasive mechanical ventilation, noninvasive ventilation, vasoactive or inotropic drug infusion, and renal replacement therapy. The study will also evaluate pain scores, opioid consumption, enteral nutrition tolerance, intra-abdominal pressure, organ function scores, complications, length of ICU and hospital stay, hospital cost, 28-day mortality, and adverse events related to thoracic epidural block.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Feng Yang, MM
- 電話番号：+8615886524007
- メール：202020321@sr.gxmu.edu.cn
参加基準
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
説明
Inclusion Criteria:
- Age 18 to 75 years.
- Diagnosis of acute pancreatitis, defined by at least two of the following three criteria: typical acute upper abdominal pain; serum amylase and/or lipase greater than three times the upper limit of normal; imaging findings consistent with acute pancreatitis on contrast-enhanced CT, MRI, or ultrasound.
- Admission or transfer to the study hospital within 72 hours after symptom onset.
- Severe acute pancreatitis, or moderately severe acute pancreatitis with early respiratory, cardiovascular, or renal organ dysfunction.
- Expected need for hospitalization and continuous clinical observation for at least 72 hours.
- Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
- Acute exacerbation of chronic pancreatitis.
- Acute pancreatitis associated with pancreatic tumor.
- Pregnancy or lactation.
- Prior percutaneous abdominal drainage, retroperitoneal drainage, endoscopic drainage, necrosectomy, or surgery before randomization that may substantially affect outcome assessment.
- End-stage malignant disease or expected survival less than 3 months.
- Severe pre-existing cardiac, pulmonary, hepatic, renal, hematologic, immune, or neurological disease judged by investigators to interfere with outcome assessment.
- Severe pre-existing neurological disease that prevents assessment of neurological complications.
- Coagulopathy or bleeding risk judged to contraindicate epidural catheterization, including severe thrombocytopenia, elevated INR, prolonged APTT, or other clinically significant coagulation abnormality.
- Ongoing anticoagulant or antiplatelet therapy for which discontinuation does not meet neuraxial anesthesia safety requirements.
- Puncture site infection, epidural abscess, central nervous system infection, or uncontrolled severe systemic infection.
- Severe spinal deformity, prior relevant spinal surgery, or anatomical abnormality that prevents safe thoracic epidural catheterization.
- Intracranial hypertension, spinal cord disease, radiculopathy, or other central nervous system disorder that contraindicates neuraxial block.
- Known allergy to local anesthetics or other study-related medications.
- Refractory shock or severe hemodynamic instability not suitable for thoracic epidural block.
- Severe psychiatric disease, cognitive impairment, or inability to cooperate with the study without availability of a legally authorized representative.
- Participation in another interventional clinical trial within the previous 3 months.
- Any other condition that, in the opinion of the investigators, makes the participant unsuitable for enrollment.
研究計画
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 |
|---|---|
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実験的：Thoracic Epidural Block Group
Participants in this group will receive thoracic epidural block and standard treatment for severe acute pancreatitis. Thoracic epidural catheterization will be performed by trained anesthesiologists after assessment of hemodynamic status, coagulation function, infection risk, respiratory status, and baseline neurological status. Epidural infusion will use ropivacaine alone. No epidural opioid, including sufentanil, fentanyl, or morphine, will be added. After successful initiation of thoracic epidural block and achievement of the analgesic target, routine intravenous opioid analgesia will not be used in this group. Intravenous analgesics will be allowed only as transitional analgesia before epidural block initiation, rescue analgesia when epidural analgesia is inadequate, or analgesia after epidural block is paused, fails, or is discontinued. All systemic analgesic use and opioid consumption will be recorded. |
Thoracic epidural block will be performed by trained anesthesiologists. Before catheterization, the clinical team will assess hemodynamic status, coagulation function, antithrombotic medication use, infection risk, respiratory status, and baseline neurological status. The puncture level will be selected according to the participant's condition and operator assessment, generally within the T7-T11 range to cover upper abdominal pain. After thoracic epidural catheter placement, a test dose of 1%-1.5% lidocaine 3 mL will be administered to exclude intrathecal or intravascular catheter placement. If the test dose is negative, a loading dose of ropivacaine may be administered, followed by continuous thoracic epidural infusion of ropivacaine alone. No epidural opioid, including sufentanil, fentanyl, or morphine, will be added to the epidural infusion in this study. A recommended regimen is 0.1%-0.2% ropivacaine, initiated at approximately 5 mL/hour and adjusted according to pain score, hemo
他の名前：
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アクティブコンパレータ：Conventional Analgesia Group
Participants in this group will receive conventional analgesia and standard treatment for severe acute pancreatitis.
Conventional analgesia may include non-steroidal anti-inflammatory drugs, acetaminophen, tramadol, fentanyl, sufentanil, oxycodone, hydromorphone, morphine, dexmedetomidine, or other analgesic and sedative medications according to clinical judgment.
Analgesic drugs, doses, routes, duration of administration, rescue analgesia, sedative use, and opioid consumption will be recorded.
|
Conventional analgesia will be administered according to institutional practice and the participant's clinical condition.
The analgesic target is an NRS score of 3 or less in conscious and communicative participants, or a CPOT score of 2 or less in non-communicative critically ill participants.
Analgesic drugs, doses, routes, duration of administration, rescue analgesia, sedative use, and opioid consumption will be recorded.
他の名前：
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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 |
|---|---|---|
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Alive Organ Support-Free Days to Day 14
時間枠：From randomization to day 14
|
Alive organ support-free days to day 14 is defined as the number of days from randomization to day 14 during which the participant is alive and free of ICU-level organ support.
ICU-level organ support includes invasive mechanical ventilation, noninvasive ventilation, continuous infusion of vasoactive or inotropic drugs, and renal replacement therapy.
A day will be counted as organ support-free only if the participant is alive and does not receive any of these organ support treatments on that day.
Participants who die within 14 days after randomization will be assigned 0 alive organ support-free days.
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From randomization to day 14
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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 |
|---|---|---|
|
Organ Failure-Free Days to Day 14
時間枠：From randomization to day 14
|
Number of days from randomization to day 14 during which the participant is alive and free of respiratory, cardiovascular, and renal organ failure.
Organ failure is defined as a SOFA subscore of 2 or higher in any of the following systems: respiratory, cardiovascular, or renal.
Participants who die within 14 days will be assigned 0 organ failure-free days.
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From randomization to day 14
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Alive Organ Support-Free Days to Day 28
時間枠：From randomization to day 28
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Number of days from randomization to day 28 during which the participant is alive and free of ICU-level organ support, including invasive mechanical ventilation, noninvasive ventilation, vasoactive or inotropic drug infusion, and renal replacement therapy.
Participants who die within 28 days will be assigned 0 days.
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From randomization to day 28
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Ventilator-Free Days to Day 28
時間枠：From randomization to day 28
|
Number of days from randomization to day 28 during which the participant is alive and free of invasive mechanical ventilation.
Participants who die within 28 days will be assigned 0 ventilator-free days.
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From randomization to day 28
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Renal Replacement Therapy-Free Days to Day 28
時間枠：From randomization to day 28
|
Number of days from randomization to day 28 during which the participant is alive and free of renal replacement therapy.
Renal replacement therapy includes continuous renal replacement therapy and intermittent hemodialysis for acute kidney injury.
Participants who die within 28 days will be assigned 0 days.
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From randomization to day 28
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Vasoactive Drug-Free Days to Day 28
時間枠：From randomization to day 28
|
Number of days from randomization to day 28 during which the participant is alive and free of vasoactive or inotropic drug infusion.
Vasoactive or inotropic drugs include norepinephrine, epinephrine, dopamine, vasopressin, dobutamine, or other agents used for shock or circulatory support.
Participants who die within 28 days will be assigned 0 days.
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From randomization to day 28
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Pain Score
時間枠：Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
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Pain intensity will be assessed using the Numeric Rating Scale in conscious and communicative participants or the Critical-Care Pain Observation Tool in non-communicative critically ill participants.
Lower scores indicate better pain control.
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Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
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Analgesic Target Achievement Rate
時間枠：From randomization to day 7
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Total systemic opioid consumption during the first 7 days after randomization, converted to intravenous morphine equivalent dose when applicable.
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From randomization to day 7
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協力者と研究者
捜査官
- スタディチェア：Xingui Dai, PHD、Chen Zhou NO.1 People's Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- TEB-SAP-001
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
米国FDA規制機器製品の研究
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