Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption
研究概览
简要总结
The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.
排除标准
- •Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.
研究组 & 干预措施
Bupivacaine 0.25%
20 cc of bupivacaine 0.25%
干预措施: Liposomal bupivacaine (Drug)
Liposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
Total Opioid Consumption
时间窗: Post op Day 1, post op Day 2, post op day 3, post op 1 week
Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.
次要结局
- Time to Discharge Home(72 hours)
- Quality of Analgesia(Post op Day 1, post op Day 2, post op day 3, post op 1 week)
- Sensory and Motor Block(at 20 min and at 1 hour)
- Time to First Pain Medicine(72 hours)
- Incidence of Postoperative Nausea and Vomiting(72 hours)
- Sleep Quality(Post op Day 1, post op Day 2, post op day 3, post op 1 week)