心脏手术后,塞拉图斯前平面块(SAP)和胸大肌块(PECS I-II)
开放心脏手术后,塞拉图斯前计划区块(SAP)和胸大肌块(PECS I-II)应用
研究概览
地位
详细说明
按照纳入标准服用并签署同意书的患者将随机分为2组。 随机分组:使用封闭的包膜方法将患者随机分为2组:
S组(将具有塞拉图斯前平面块的人):手术后,接受冠状动脉搭桥手术的患者将被带到心血管重症监护病房。 将进行必要的准备工作以制造一个SAP块。 在确保前胸壁的卫生状态后,在超声指导下,它具有8厘米长的外围块针头。 SAP阻滞是一种局部麻醉注射程序,可表面或深层施用到前肌,并专门针对肋间神经的外侧皮肤和肌肉分支。 长胸神经和胸神经位于塞拉图斯前肌表面的筋膜平面中,可以阻塞。 可以在前腋线和第二肋骨和第7肋骨之间进行塞拉图斯前块。 它是与患者在仰卧位置进行的,同侧臂被绑架90度或在侧向板侧位置,而手术侧向上,同一侧臂向前弯曲并向前延伸。 SAP块将在第四肋骨的水平上执行。 注射位点可以通过以旁皮方式将超声探针放在锁骨下,并从第二肋骨计算。 通过将探针侧向移动到中腋中或后腋线,塞拉图斯前肌将被视为肋骨的消声阴影上的一层肌肉。 它延伸到拉特氏肌前肌前肌,在腋后线中看起来更厚,更突出。 针头将在表面上或深肌前进到前肌,并将30 mL局部麻醉(布比卡因)施用到筋膜平面上。
P组(PECS I-II):接受冠状动脉搭桥手术的患者将被带到术后重症监护病房。 将准备PECS块的准备,并在确保前胸壁卫生后,在超声指导下将进行8厘米长的外围块针头。 PECS II块是PECS I和瞄准肋骨间神经,长胸腔和胸腔神经的外侧皮肤分支的局部麻醉注射的组合。 为了执行pecs i阻止,将超声探针放置在锁骨中间线和旁层面,并可视化胸腔大少量,腋窝血管和胸膜。 通过尾部滑动超声探针识别第二和第三肋骨后,下端将朝腋窝旋转,使探针平行于三角洲胸腔凹槽。 结合面内技术,这种旋转为术间神经提供了更好的扩展。 针头将放置在室内筋膜平面(胸大肌和小型)和15毫升局部麻醉(布比卡因)中。 为了执行PECS II块,除了pecs i阻滞外,针头还从际筋膜平面前进到胸大肌小和前部的筋膜平面。 15毫升或局部麻醉(布比卡因)将被注入该区域(对于15毫升PECS I,总计30ml局部麻醉剂,用于15ml PECS II)。 与研究无关的研究者将使用计算机生成的随机表进行随机分组。 检测比为1:1,密封的不透明信封将用于隐藏分配。 结果评估者和外科医生将不知道小组分配。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Tuşba
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Van、Tuşba、土耳其(türkiye)、65080
- Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 同意参加研究,
- 20-65岁
- asa i-ii-iii
- 心脏手术
排除标准:
- 拒绝参加这项研究
- 20岁,65岁以上
- 怀孕
- 存在出血
- 肝或肾脏衰竭
- 接受有效的免疫治疗
- 免疫抑制了BMI≥30的人
学习计划
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 |
|---|---|
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实验性的:Bilateral SAP Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side.
To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes.
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Ultrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting.
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有源比较器:Bilateral PECS II Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side.
To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes.
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Ultrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting.
On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles.
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安慰剂比较:Sham Block
Participants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding.
All participants received the same standardized postoperative systemic analgesic regimen.
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Ultrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting.
On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding.
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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 |
|---|---|---|
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Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
大体时间:4, 8, 12, and 24 hours after extubation
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Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
Assessments will be performed at 4, 8, 12, and 24 hours after extubation.
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4, 8, 12, and 24 hours after extubation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative nausea and vomiting (PONV)
大体时间:Within 24 hours after surgery
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The occurrence of postoperative nausea and/or vomiting will be recorded during the first 24 hours after surgery.
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Within 24 hours after surgery
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Block-related complications
大体时间:During hospitalization
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Block-related complications, including local anesthetic systemic toxicity, hematoma, infection, pneumothorax, vascular puncture, nerve injury, or other procedure-related adverse events, will be recorded.
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During hospitalization
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Length of intensive care unit (ICU) stay
大体时间:From ICU admission to ICU discharge (assessed up to 30 days).
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Length of stay in the intensive care unit (ICU), measured in hours from ICU admission to ICU discharge.
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From ICU admission to ICU discharge (assessed up to 30 days).
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Time to first mobilization
大体时间:From ICU admission to first mobilization (assessed up to 7 days).
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Time from ICU admission to first mobilization, measured in hours.
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From ICU admission to first mobilization (assessed up to 7 days).
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Duration of mechanical ventilation
大体时间:From ICU admission to successful extubation (assessed up to 7 days).
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Duration of mechanical ventilation, measured as the time from ICU admission to successful extubation, in hours.
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From ICU admission to successful extubation (assessed up to 7 days).
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Total tramadol and pethidine consumption within the first 24 postoperative hours
大体时间:Within the first 24 postoperative hours
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Cumulative intravenous tramadol and pethidine doses administered during the first 24 postoperative hours will be recorded and reported separately in milligrams.
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Within the first 24 postoperative hours
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合作者和调查者
调查人员
- 学习椅:School of Mdicine Department of Anesthesiology and Reanimation、Yuzuncu Yil University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 17/05/2023
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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