NCT07490496尚未招募3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Postoperative Pain with activity
研究概览
简要总结
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
详细描述
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Concomitant conditions
结局指标
主要结局
Postoperative Pain with activity
时间窗: 24 hours
AUC NRS-A wWOCF
次要结局
- Postoperative Pain with rest(24 hours, 72 hours)
- Postoperative rescue medication use(24 hours, 72 hours)
研究者
研究点 (1)
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