Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pain on 11-point Visual Analog Score Scale (VAS)
研究概览
简要总结
The investigators will assess the use of Transcutaneous Neurostimulation (TENS), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent. Secondary aim will be to assess if it can help minimize narcotic use.
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
- •Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
- •Patients receiving a stent following their ureteroscopy and laser lithotripsy
排除标准
- •Pregnant patients
- •Patients unable to answer pain questionnaire
- •Patients undergoing PCNL
- •Patients being treated for Urologic malignancy with ureteroscopy
- •Patients who require long term or chronic ureteral stent management
- •Patient with implantable stimulators
- •Patient with epilepsy
- •Patients undergoing laser lithotripsy without stent placement
研究组 & 干预措施
Standard care
Participants will follow standard care until the ureteral stent is removed
TENS device
Participants will use the TENS device until the ureteral stent is removed
干预措施: TENS (Device)
结局指标
主要结局
Pain on 11-point Visual Analog Score Scale (VAS)
时间窗: Assessed daily until removal of stent, approximately 3-10 days after placement
Cumulative average pain score using an 11-point VAS. The VAS is a validated tool widely used to assess pain intensity. Possible score ranges: * Scale for back pain: 0 (no pain) - 10 (worst pain) * Abdominal/Groin Pain: 0 (no pain) - 10 (worst pain) * Pain Frequency: 0 (not at all) - 10 (All day or night long) * Nausea intensity: 0 (No nausea) - 10 (Worst possible nausea)
Difference in Pain on 11-point Visual Analog Score Scale (VAS)
时间窗: Assessed daily until removal of stent, approximately 3-10 days after placement
Cumulative average difference in pain score using an 11-point VAS. The VAS is a validated tool widely used to assess pain intensity. Possible score ranges: * Scale for back pain: 0 (no pain) - 10 (worst pain) * Abdominal/Groin Pain: 0 (no pain) - 10 (worst pain) * Pain Frequency: 0 (not at all) - 10 (All day or night long) * Nausea intensity: 0 (No nausea) - 10 (Worst possible nausea)
次要结局
- Total Opioid Consumption(Until stent removal (up to 10 days))
- Difference in Total Opioid Consumption(Until stent removal (up to 10 days))
- Ureteral Stent Discomfort Test (USDT) Scale Score(Assessed at removal of stent, approximately 3-10 days after placement)
- Patient Satisfaction Survey(End of study (day 3 to 10))
研究者
Simon Conti
Clinical Assistant Professor, Urology
Stanford University