Evaluating The Role Of Corticosteroids In Post-Ureteroscopy Recovery For Urinary Calculi
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale Pain Score
研究概览
简要总结
The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications
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, Care Provider, Investigator)
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
- •Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen or pelvis) and who elect for definitive treatment via ureteroscopy with placement of ureteral stent.
- •Age 18 years or older
- •Patients of either gender
- •Patients of all ethnic backgrounds
- •Cable of giving informed consent
- •Capable and willing to fulfill the requirements of the study.
排除标准
- •History of chronic pain
- •Chronic use of opioids or other pain medication (>12 weeks)
- •Known allergies to corticosteroids.
- •Known or suspected pregnancy
- •Inability to give informed consent or unable to meet requirements of the study for any reason.
- •Bilateral ureteroscopy
- •Current Corticosteroid Use
- •Diabetic patients who are insulin dependent
研究组 & 干预措施
Standard of care plus Corticosteroid
Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg.
干预措施: Corticosteroid (Drug)
Standard of Care
Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Visual Analog Scale Pain Score
时间窗: Baseline, Day 1 (Post-operatively), Day 2, Day 3
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
次要结局
- Number of times non-opioid analgesics medication used(3 days)
- Cumulative usage of non-opioid analgesics medication(3 days)
- Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score(Day 2 (Post-operatively), Day 3)
- Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score(Day 1 (Post-operatively), Day 2, Day 3)
研究者
Karen L. Stern
Principal Investigator
Mayo Clinic