NCT02695758已完成不适用
Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 主要终点
- Morphine and Morphine Equivalent consumption
研究概览
简要总结
A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.
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
- •1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.
排除标准
- •Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- •Revision arthroplasty, arthroplasty for fracture
- •Unable/unwilling to consent for enrollment
- •Unable to complete postoperative pain survey
- •Known adverse drug reaction or allergy to the medications used
- •Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
- •Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
- •Patients under the age of 18 years
- •Patients with history of hepatic disease
- •Pregnant women or women who are breastfeeding
研究组 & 干预措施
interscalene brachial plexus block
Active Comparator
Direct interscalene nerve block injection via brachial plexus
干预措施: Interscalene brachial plexus block (Procedure)
Bupivacaine extended-release liposome injection
Active Comparator
Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues.
干预措施: bupivacaine extended-release liposome injection (Procedure)
结局指标
主要结局
Morphine and Morphine Equivalent consumption
时间窗: 24 hours following surgery
次要结局
未报告次要终点
研究者
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