Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- NRS scores of patients
研究概览
简要总结
Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.
详细描述
46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages of 18-65
- •Patients who will undergo spine surgery (at least two level)
- •ASA I-II-III patients
排除标准
- •Clinically known local anesthetic allergy
- •Morbid obesity (body mass index>40 kg m2)
- •Clinically diagnosis of opioid, alcohol and substance dependence
- •Clinically diagnosis of psychiatric disease
- •Coagulopathy
- •Patients with ASA IV-V
- •Single level surgery
结局指标
主要结局
NRS scores of patients
时间窗: 48 hours postoperatively
NRS at 1, 6,12, 18, 24, 36, 48th hours
次要结局
- Postoperative 48-hours total morphine consumption(48 hours postoperatively)
研究者
Gokhan Sertcakacilar, MD
Principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital