NCT07308717招募中4 期
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,896
- 试验地点
- 13
- 主要终点
- Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy
研究概览
简要总结
This study aims to assess whether gabapentin should be a standard component of peri-operative pain control in mastectomy patients at Memorial Sloan Kettering Cancer Center.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •Undergoing ambulatory extended recover (AXR) mastectomy (bilateral or unilateral) at the Josie Robertson Surgical Center (JSRC)
排除标准
- 未提供
结局指标
主要结局
Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy
时间窗: Up to 46 months
Determine the effect of peri-operative gabapentin use on pain control in the PACU operationalized as the top quartile of postoperative morphine milligram equivalents/MMEs required in participants undergoing mastectomy
次要结局
未报告次要终点
研究者
研究点 (13)
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