Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 60 years
- •Body Mass Index (BMI) < 35 kg/m²
排除标准
- •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
研究组 & 干预措施
Group E (n=30)
Erector Spinae Plane Block
干预措施: Erector Spinae Plane Block (ESPB) (Procedure)
Group R (n=30)
Rectus Sheath Block
干预措施: Rectus Sheath Block (RSB) (Procedure)
结局指标
主要结局
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
时间窗: 24 hours after block performance
The time interval between the block performance and the first request of postoperative analgesia
次要结局
- Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)(24 hours after block performance)
- Number of participants and Rate of Postoperative Complications(24 hours after block performance)
- Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)(24 hours after block performance)