NCT03738696已完成4 期
Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Average Postoperative Pain Scores Over a 96 Hour Timeframe
研究概览
简要总结
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing outpatient arthroscopic rotator cuff repair
- •Greater than or equal to 19 years of age at the time of surgery
排除标准
- •Planned operative fixation of the biceps tendon or acromioclavicular joint
- •Opioid use 6 weeks before surgery
- •Gabapentin use 6 weeks before surgery
- •History of prior shoulder surgery on the operative limb
- •Severe pulmonary dysfunction
- •Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
- •History of radicular pain or neuropathy in the operative limb
- •Patients who are currently incapacitated for medical decision making
研究组 & 干预措施
Ropivacaine Interscalene Catheter
Active Comparator
- 20cc 0.25% bupivacaine interscalene block; PLUS
- Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
干预措施: Ropivacaine (Drug)
Liposomal bupivacaine Interscalene Block
Experimental
Interscalene block:
- 10cc (133mg) liposomal bupivacaine;PLUS
- 10cc 0.25% bupivacaine
干预措施: Exparel (Drug)
结局指标
主要结局
Average Postoperative Pain Scores Over a 96 Hour Timeframe
时间窗: Up to 96 hrs postoperative
Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]
次要结局
- Average Hours of Painless Sleep(Up to 96 hrs postoperative)
- Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe(Up to 96 hrs)
- Average Sleep Quality Over a 96 Hour Timeframe(Up to 96 hrs postoperative)
- Percentage of Participants With Analgesia Complications(Up to 96 hrs)
- Average Analgesia Satisfaction Over a 96 Hour Timeframe(Up to 96 hrs)
研究者
Amit Momaya
Associate Professor, Orthopaedic Surgery
University of Alabama at Birmingham
研究点 (1)
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