US 引导的 EOI 阻滞与 ESPB 对比用于腹腔镜胆囊切除术后镇痛
超声引导腹外斜肋间 (EOI) 阻滞与竖脊肌平面阻滞 (ESPB) 用于腹腔镜胆囊切除术后镇痛
To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Magdy M mahdy, MD
- 电话号码：0109 650 2058
- 邮箱：magdymahdy84@yahoo.com
研究联系人备份
- 姓名：Amr M.A. Thabet, MD
- 电话号码：01068924262
- 邮箱：Amrthabet@aun.edu.eg
学习地点
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-
Assiut, Asyut Governorate, Egypt,
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Asyut、Assiut, Asyut Governorate, Egypt,、埃及
- 招聘中
- Assiut University hospital
-
接触：
- Magdy M Mahdy, Lecturer
- 电话号码：01096502058
- 邮箱：magdy.mahdy@aun.edu.eg
-
-
参与标准
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 between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective laparoscopic cholecystectomy.
Exclusion Criteria:
- Allergy to local anaesthetics,
- Infection at the site of injection,
- Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
- Patients who received any analgesic 24 h before surgery.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：外斜肋间 (EOI) 阻滞
|
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side. |
|
有源比较器：竖脊肌平面阻滞 (ESPB)
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A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side. |
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 |
|---|---|---|
|
Nalbuphine consumption in mg equivalent to morphine dose.
大体时间：24 hours postoperatively
|
mg |
24 hours postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numerical Rating Scale (NRS) at rest and when coughing
大体时间：at 1, 2,4 , 8, 16 and 24 hours postoperatively
|
11-point scale where 0=no pain and 10=worst pain |
at 1, 2,4 , 8, 16 and 24 hours postoperatively
|
|
Analgesic drug consumption other than nalbuphine
大体时间：24 hours postoperatively
|
in mg |
24 hours postoperatively
|
|
Heart Rate
大体时间：Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
|
beats /min |
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
|
|
Mean Arterial Pressure
大体时间：Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
|
mmHg |
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
|
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Incidence of Postoperative nausea & vomiting (PONV)
大体时间：24 hours postoperatively
|
Number of patients developing PONV |
24 hours postoperatively
|
|
Shoulder pain
大体时间：24 hours postoperatively
|
Number of patients developing Shoulder pain |
24 hours 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)
初级完成 (估计的)
研究完成 (估计的)
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
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