NCT04494880已完成早期 1 期
Marcaine Post-Operative Pain Study
State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年12月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
研究概览
简要总结
The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be receiving bilateral breast reduction surgery
排除标准
- •Unilateral breast reduction surgery
研究组 & 干预措施
Treatment Group (Marcaine 1 Breast)
Experimental
Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
时间窗: through study completion, an average of 1 year
Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes
次要结局
未报告次要终点
研究者
研究点 (1)
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