Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Numerical Rating Scale (NRS) Pain Score
研究概览
简要总结
This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.
排除标准
- •Patients with known allergies to local anesthetics
- •pregnant patients
- •patients with a history of liver disease
- •patients undergoing bilateral procedures
- •Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques
- •Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.
研究组 & 干预措施
Exparel
This arm will receive Exparel
干预措施: Exparel (Drug)
结局指标
主要结局
Change in Numerical Rating Scale (NRS) Pain Score
时间窗: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.
次要结局
- Change in Home Opioid Use(Day of Surgery, Post-Operative Day 6 (Up to 144 hours))
- Difference in Time to First Opioid Use(Day of Surgery, Post-Operative Day 6 (Up to 144 hours))
研究者
John Xerogeanes
Associate Professor
Emory University