Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 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 analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation
详细描述
The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Aged 18-65 years.
- •Both genders.
- •American Society of Anesthesiologists' (ASA) physical status I or II.
- •Undergoing single level lumbar spine fixation.
排除标准
- •Patient refusal.
- •Pregnant females.
- •Renal, lung, heart, or liver disorders.
- •Communication difficulties which might prevent a reliable postoperative assessment.
- •Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
- •BMI more than 30 kg/m2.
研究组 & 干预措施
Erector 10
Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
Erector 15
Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
Erector 20
Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: First 24 hours postoperatively
Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded
次要结局
- Numerical rating scale(Up to 48 hours postoperatively)
- Time to the first rescue analgesic(Up to 24 hours postoperatively)
- Postoperative complications(Up to 24 hours postoperatively)
- 5-point scale(Up to 24 hours postoperative)
研究者
Mohamed Fouad Algyar
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt
Kafrelsheikh University