Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery: a Randomized Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Time to first request of postoperative rescue analgesics
研究概览
简要总结
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery.
详细描述
Introduction:
Regional anesthesia is a key component of opioid-sparing multimodal analgesia after major abdominal surgery as it improves recovery such as return of bowel function and early ambulation. Continuous epidural local anesthetic infusion is a common analgesic technique but comes with the side effect of hypotension and potential leg weakness and rarely, epidural abscess or hematoma. The rectus sheath block (RSB) has been used for postoperative analgesia in surgical procedures involving a vertical midline laparotomy incision as well as for laparoscopic procedures. In this block the ventral rami of the seventh intercostal nerve up to the subcostal nerve, which supply the rectus abdominis muscle and overlying skin, are blocked.
Recently, the erector spinae plane block (ESPB) has gained wide attention due to its simplicity and potential uses in truncal procedures. This paraspinal plane block is performed by injecting local anesthetic between the erector spinae muscles and transverse processes and is thought to work by blocking the dorsal and ventral rami of the thoracic spinal nerves. Injections at various thoracic levels have been described in case reports with satisfactory postoperative analgesia for breast, thoracic and abdominal procedures. Comparison of post-operative pain management of both erector spinae plane block and rectus sheath block in adults undergoing major abdominal surgery for has not been investigated before.
Hypothesis:
It is hypothesized that ESPB is more effective in postoperative analgesia following major abdominal surgeries with minimal motor affection and postoperative morphine consumption compared to RSB block.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II. Age: 18 to 60 years. Undergoing midline vertical laparotomy incisions (open colorectal resections or major ventral hernia repair).
排除标准
- •Refusal of patients.
- •Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5).
- •History of allergic reactions to local anesthetics.
- •Rash or signs of infection at the injection site.
- •Emergency surgery.
结局指标
主要结局
Time to first request of postoperative rescue analgesics
时间窗: 24 hours
the time interval between the block performance and the first request to postoperative analgesia and or VAS ≥ 4
次要结局
- Block performance time in min(procedure (time from probe contact with skin till needle withdrawal))
- Total consumption of morphine(24 hours)
- Visual analogue score at rest (static), and on movement or coughing (dynamic)(24 hours)
- Incidence of perioperative complications.(24 hours)
- Failure rate of the block(1st postoperative hour)
研究者
Khaled Abdelfattah Abdallah Sarhan
principal investigator
Kasr El Aini Hospital