A Randomized, Double-blind Controlled Trial of Bupivacaine Extended-release Liposome Injection for Postsurgical Analgesia in Patients Undergoing Open-reduction Internal Fixation of the Distal Radius
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 主要终点
- Pain Medication Usage
研究概览
简要总结
For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease the need for post-operative narcotic pain medication.
详细描述
TITLE OF THE RESEARCH PROJECT A randomized, double-blind controlled trial of bupivacaine extended-release liposome injection for post-surgical analgesia in patients undergoing open-reduction internal fixation of the distal radius.
PROJECT SUMMARY For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease the need for post-operative narcotic pain medication.
STATEMENT OF THE PROBLEM Patients undergoing open-reduction internal-fixation (ORIF) of isolated distal radius fractures experience significant post-operative pain, most commonly mitigated by the use of narcotic painkillers. Among other issues, prolonged use of narcotic painkillers can lead to dependence and abuse. This potentially leads to post-operative narcotic seeking habits of adult orthopedic trauma patients.
THEORETICAL FRAMEWORK There is much research supporting that administration of liposomal bupivacaine is an effective post-surgical analgesic. The investigators' hypothesis is that 66.5 mg of liposomal bupivacaine injected at the operative field will decrease the need for post-operative narcotics, and will therefore reduce the risk of dependence and abuse.
RESEARCH OBJECTIVE
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated distal radius fracture
排除标准
- •No Access to a telephone
研究组 & 干预措施
Active Group
Group that receives actual liposomal bupivacaine injections
干预措施: Exparel (Drug)
Placebo Group
Group that receives placebo injections
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Medication Usage
时间窗: three days
the amount of pain medication used in the three days following surgery.
次要结局
- Total Narcotic Pain Medication Usage(7 days after surgery)
- Passive Wrist Range of Motion(7 days after surgery)
- Over Satisfaction(7 days after surgery)
研究者
David Seligson
Principal investigator
University of Louisville