Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
详细描述
Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.
Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.
One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of the patient between 21 to 65 years.
- •Both sexes.
- •Body mass index (BMI): 20 - 40 kg/m
- •American Society of Anesthesiologists (ASA) physical status II-III.
- •Elective radical cystectomy.
排除标准
- •Patient refusal.
- •Psychiatric and cognitive disorders.
- •Local infection at the site of injection.
- •Allergy to study medications.
- •Anatomic abnormalities.
- •Inability to comprehend or participate in pain scoring system.
研究组 & 干预措施
Erector Spinae Plane Block group
Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.
干预措施: Bupivacain 25% (Erector Spinae Plane Block) (Drug)
Intravenous patient-controlled analgesia group
Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine
干预措施: Morphine (Intravenous patient-controlled analgesia) (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 48 hours postoperatively
Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.
次要结局
- Degree of pain(48 hours postoperatively)
- Incidence of side effects(48 hours postoperatively)
- The time of first rescue analgesia(48 hours postoperatively)
研究者
Tarek Ezzat Abd El Galil
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
Kafrelsheikh University