Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain Intensity Score at Rest at 24 Hours Post-operatively
研究概览
简要总结
This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.
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
盲法说明
Unblinded
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
liposomal bupivacaine single-shot interscalene blockade
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
干预措施: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj (Drug)
continuous interscalene nerve blockade
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Pain Intensity Score at Rest at 24 Hours Post-operatively
时间窗: Post-Operative Day 1
Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.
次要结局
- Cumulative Opioid Consumption(PACU to postoperative day 3)
- Quality of Recovery Score (QoR)(Post-Operative Day 1)
研究者
Jason K. Panchamia, D.O.
Principal Investigator
Mayo Clinic