Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Adverse Events Related to Study Drug
研究概览
简要总结
The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There will be no blinding for this pilot
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pregabalin 300mg
300mg pregabalin, PO, once, 1 hr before surgery
干预措施: Pregabalin 300mg (Drug)
结局指标
主要结局
Number of Participants With One or More Adverse Events Related to Study Drug
时间窗: Day of surgery
Number of Participants Who Were Administered the Study Drug Correctly
时间窗: Day of surgery
Respondent Reported Usability of Instruments
时间窗: 30 days post-op
Number of patients able to complete 30 day post op questionnaire
次要结局
- Opioid Use(Up to 1 year post-op)
- Unplanned Healthcare Contacts(First 30 post-operative days)
- Amount of Opioid Use(Up to 1 year post-op)
- Early Post-op Stent Related Symptoms(Post-op day 3)
- Early Post-op Opioid Needs(First 30 post-operative days)
- Patient Satisfaction(First 30 post-operative days)
研究者
Katie Murray
Assistant Professor
University of Missouri-Columbia