胸横肌平面阻滞与胸肋间筋膜阻滞对心脏手术后加速康复的效果比较
胸横肌平面阻滞与胸肋间筋膜阻滞用于心脏手术后加速康复:一项随机对照试验
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
详细说明
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
研究类型
研究类型
注册 (实际的)
注册
阶段
阶段
- 不适用
联系人和位置
学习地点
-
-
Asyut Governorate
-
Asyut、Asyut Governorate、埃及、71515
- Assiut University
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Exclusion Criteria:
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
- Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
- Known hypersensitivity or a history of allergy to local anesthetics.
- Had severe major organ dysfunction.
- Left ventricular ejection fraction below 30%.
- Pregnancy or breastfeeding.
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:双倍的
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
实验性的:Group PIFB
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
|
实验性的:Group TTPB
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
|
假比较器:Control Group
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total amount analgesic requirement
大体时间:24 hours postoperatively
|
In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given. |
24 hours postoperatively
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Degree of pain
大体时间:24 hours postoperatively
|
Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain). NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery. |
24 hours postoperatively
|
|
The number of patients required rescue analgesia
大体时间:24 hours postoperatively
|
The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation. |
24 hours postoperatively
|
|
Postoperative nausea and vomiting (PONV)
大体时间:24 hours postoperatively
|
The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once. |
24 hours postoperatively
|
|
Time to extubation
大体时间:24 hours postoperatively
|
After the operation, the time until the patient is extubated will be recorded. |
24 hours postoperatively
|
|
Length of stay in the intensive care unit.
大体时间:Average 7 days postoperatively
|
The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days. Total duration of stay in ICU will be recorded. |
Average 7 days postoperatively
|
|
Assessment of Delirium
大体时间:24 hours postoperatively
|
Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. It will be evaluated 24 hrs after extubation. |
24 hours postoperatively
|
|
Level of patient satisfaction
大体时间:24 hours postoperatively
|
Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied). |
24 hours postoperatively
|
|
Incidence of complications.
大体时间:7 days postoperatively
|
Any complications-directly related to the block or the drug used in the block- will be recorded. Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock. |
7 days postoperatively
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- 04-2026-300788
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
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
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
在美国制造并从美国出口的产品
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