竖脊肌平面阻滞与直肌鞘阻滞对比用于脐上手术后的术后镇痛
竖脊肌平面阻滞是否比直肌鞘阻滞更有效用于成年患者脐上手术后的术后镇痛
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
研究概览
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:Ahmed M Shaat, MD
- 电话号码:00201223482709
- 邮箱:ahmedshaat99@gmail.com
学习地点
-
-
El-Beheira
-
Damanhūr、El-Beheira、埃及
- 招聘中
- Damanhour Teaching Hospital
-
接触:
- Ahmed M Shaat, MD
- 电话号码:00201223482709
- 邮箱:ahmedshaat99@gmail.com
-
-
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:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Group E (n=30)
Erector Spinae Plane Block |
Postoperative Bilateral Ultrasound-guided ESPB |
|
有源比较器:Group R (n=30)
Rectus Sheath Block |
Postoperative Bilateral Ultrasound-guided RSB |
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 |
|---|---|---|
|
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
大体时间:24 hours after block performance
|
The time interval between the block performance and the first request of postoperative analgesia |
24 hours after block performance
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
大体时间:24 hours after block performance
|
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance |
24 hours after block performance
|
|
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
大体时间:24 hours after block performance
|
The total dose of the rescue analgesic consumed in the first 24 hours after block performance |
24 hours after block performance
|
|
Number of participants and Rate of Postoperative Complications
大体时间:24 hours after block performance
|
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax |
24 hours after block performance
|
合作者和调查者
调查人员
- 首席研究员:Ahmed M Shaat, MD、Damanhour Teaching Hospital
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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