NCT06474949尚未招募4 期
Local Anesthetic for Plateau Fractures
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
研究概览
简要总结
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay
详细描述
Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient is asleep at time of injection
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
- •Age >=18 year ,
- •tibial plateau fracture undergoing Open Reduction and fixation"
- •allergy to bupivacaine
- •Prolonged external fixator use
排除标准
- 未提供
研究组 & 干预措施
Bupivacaine
Active Comparator
Bupivacaine
干预措施: Bupivacaine injection (Drug)
Saline
Placebo Comparator
Saline
干预措施: Saline (Other)
结局指标
主要结局
Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
时间窗: From date of hospitalization to end of follow-up at 6 months
Pain at time of visit
次要结局
- Length of stay for hospitalization(From date of hospitalization up to one month post surgery)
研究者
Jonah Hebert-Davies
Assistant Professor, School of Medicine: Orthopedics
University of Washington
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