NCT04047745Unknown不适用
The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
- •Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.
排除标准
- •Revision shoulder surgery
- •History of more than 1 prior surgery performed on the operative shoulder
- •Concomitant severe glenohumeral arthritis
- •Concomitant adhesive capsulitis
- •Worker's compensation claim
- •Pregnancy
- •History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- •History of renal or hepatic failure
- •Chronic neuromuscular deficit affecting the surgical limb.
- •Uncontrolled psychiatric or neurologic disorder
研究组 & 干预措施
liposomal bupivacaine
Active Comparator
干预措施: Liposomal bupivacaine (Drug)
ropivacaine
Active Comparator
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
opioid consumption
时间窗: surgery through 48 hours post-op
postsurgical opioid consumption
次要结局
未报告次要终点
研究者
研究点 (1)
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