Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- NRS (numeric rating scale) score for coughing pain
研究概览
简要总结
This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •ASA I-III
- •Open liver surgery
排除标准
- •Contraindication to nerve block or epidural puncture
- •Chronic use of opioids or NSAIDs
- •Refused to participate in the study
研究组 & 干预措施
Quadratus lumborum block
Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament.
干预措施: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament (Procedure)
Thoracic epidural analgesia
Thoracic epidural analgesia at the level of T7-10.
干预措施: Thoracic epidural analgesia (Procedure)
结局指标
主要结局
NRS (numeric rating scale) score for coughing pain
时间窗: at 24 hours after surgery
Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
次要结局
- The incidence of pruritus(during 72 hours after surgery)
- NRS score for rest and coughing pain(at 1, 6, 24, 48, 72 hours after surgery)
- Time to eat in days(through study completion, an average of 2-3 days)
- Time to defecation in hours(through study completion, an average of 60-70 hours)
- Postoperative hospital stay in days(through study completion, an average of 7-8 days)
- Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication(One month after surgery)
- Numbers of additional analgesics(during 72 hours after surgery)
- The incidence of postoperative hypotension(during 72 hours after surgery)
- The incidence of nausea and vomiting(during 72 hours after surgery)
- Time to urethral catheter removal in hours(through study completion, an average of 60-70 hours)
- The incidence of respiratory depression(during 72 hours after surgery)
- consumption of opioid converted to IV morphine equivalents(during 24 hours after surgery)
- Time to ambulation in days(through study completion, an average of 2-3 days)
- Time to flatus in hours(through study completion, an average of 40-50 hours)
研究者
Huifang Jiang
Principal Investigator
Zhejiang Cancer Hospital