Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing Retrograde Intrarenal Surgery (RIRS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative pain level
研究概览
简要总结
This study will include patients aged between 18 and 70 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 40 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the level of pain felt by patients in the postoperative period.
详细描述
The level of pain of the patients in both groups will be evaluated by using visual analog score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th min and 120th min.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 18-70 years old
- •Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
排除标准
- •Patients with uncontrolled diabetes mellitus and diabetic nephropathy
- •Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s)
- •Patients with chronic kidney failure who need dialysis
- •Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
- •Patients who have had pyelonephritis 3 months or much earlier
- •Patients younger than 18 years or older than 70 years
- •Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
- •Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
- •Patients using any kind of medication that can affect his/her perception of pain
结局指标
主要结局
Postoperative pain level
时间窗: Within the first 2 hours after the surgery (RIRS)
Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).
次要结局
未报告次要终点
研究者
Ozcan Kilic
M.D., Assoc. Prof. Dr.
Selcuk University