NCT07280195Enrolling By Invitation4 期
ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
干预措施
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Narcotic consumption
研究概览
简要总结
The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.
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
- •Adult patients 18 years or older
- •Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)
排除标准
- •Any persons unable to consent, will not be eligible
- •Patients undergoing revision arthroplasty or reverse shoulder arthroplasty
- •Proximal humerus fractures
- •Inability to have interscalene anesthetic catheter placement
- •Compromised baseline renal function (CrCl < 50)
- •History of GI bleed, prior duodenal surgery, or gastric sleeve resection
- •Current narcotic use or prior consistent narcotic exposure in the last 6 months
- •Use of perioperative oral steroid medications
- •Active Workman's compensation claim
- •Prior shoulder arthroplasty on the contralateral side in which an interscalene catheter was used
研究组 & 干预措施
ZYNRELEF
Active Comparator
干预措施: Zynrelef (Drug)
Interscalene block with continuous catheter pump
Active Comparator
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Narcotic consumption
时间窗: From surgery to two-weeks following surgery
Narcotic consumption measured in morphine equivalent units (MEU)
次要结局
- Pain management cost(Perioperative)
- Pain management administration(Perioperative)
研究者
Alexander Aleem
Associate Professor
Washington University School of Medicine
研究点 (1)
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