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Continuous ESP Block in Patients Undergoing CABG Surgery.

2026年6月18日 更新者：Filomena R B G Galas、Instituto do Coracao

Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.

This study addresses articles and studies related to the erector spinae plane (ESP) block and its technique, advantages and disadvantages, applicability, among others. It aims to provide more information about this block, which is relatively new, and how it can be explored in the anesthesiologist's routine, mainly inserted in the anesthesia scenario for cardiac surgery with a focus on postoperative analgesia.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.

All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .

研究类型

介入性

注册 (估计的)

78

阶段

  • 第三阶段

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。

学习联系方式

学习地点

  • 巴西
    • São Paulo
      • São Paulo、São Paulo、巴西
        • 招聘中
        • InCor

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Consent to the free and informed consent term.
  • Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
  • Preserved left ventricular global function (LVEF > 50%).

Exclusion Criteria:

  • Moderate or severe valvular dysfunction.
  • Previous anterior sternotomy.
  • Known allergy to the study drugs.
  • Complications during catheter insertion or block placement.
  • Pre-existing diagnosed chronic pain under treatment.
  • Concomitant use of drugs with a long half-life (induction and anesthetic maintenance doses will be standardized; patients taking medications with a long half-life are excluded to prevent bias in outcome assessment).
  • Concomitant administration of Magnesium Sulfate.

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：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：ESP Block Ropivacaine PCA group
Local anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump. Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing.
药品：Ropivacaine
Bilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL).
药品：Standard Postoperative Analgesics
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
安慰剂比较：ESP Block placebo PCA group
Group that will serve as a comparison for blockade with analgesia. That is, this group had received a placebo solution. Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side). After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger.
药品：Standard Postoperative Analgesics
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
药品：Placebo (0.9% Sodium Chloride)
Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator.

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
Total morphine consumption
大体时间：From surgery completion up to postoperative day 5
Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record. All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents
From surgery completion up to postoperative day 5

次要结果测量

结果测量
措施说明
大体时间
Chronic pain scores at 30 days
大体时间：30 days after intervention.
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
30 days after intervention.
Chronic pain scores at 180 days
大体时间：180 days after intervention.
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
180 days after intervention.

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。

赞助

Instituto do Coracao

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)

2024年12月12日

初级完成 (估计的)

2027年12月12日

研究完成 (估计的)

2027年12月12日

研究注册日期

首次提交

2022年9月26日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 29585120.1.0000.0068

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

不

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