Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Opioid Utilization
研究概览
简要总结
This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing total shoulder arthroplasty;
- •Patients who consent to be randomized.
排除标准
- •Patients younger than 18 and older than 75;
- •Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
- •Patients who are allergic to oxycodone;
- •Patients who are unable to speak English;
- •Patients with diagnosed or self---reported cognitive dysfunction;
- •Patients with a history of neurologic disorder that can interfere with pain sensation;
- •Patients with a history of drug or recorded alcohol abuse;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- •Patients with BMI over 40;
- •Any patient that the investigators feel cannot comply with all study related procedures;
- •NYU Langone Health students, residents, faculty or staff members
研究组 & 干预措施
20 mL 0.5% Bupivacaine HCL
干预措施: 0.5% Bupivacaine HCL (Drug)
Interscalene nerve block with Liposomal + Bupivacaine 0.5%
Administered in an Interscalene block for TSA
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Opioid Utilization
时间窗: 24-72 hour, Post-Operative Period
Measure in morphine milligram equivalents \[MME\]
次要结局
- Opioid Utilization(Day 4-7, Post-Operative Period)
- Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale(Day 1-7, Post-Operative Period)
- T-Scores, PROMIS Pain Intensity Scale(Day 1-7, Post-Operative Period)