Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
研究概览
简要总结
Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy.
This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.
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
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged ≥ 18 years old.
- •Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting.
排除标准
- •Foley catheterization
- •History of allergy to bupivacaine
- •Antegrade ureteroscopy
- •Transplant or ectopic kidney
- •Ureteral or bladder reconstruction
- •Pregnancy (which is a contraindication to elective ureteroscopy)
- •Surgical complication (significant bleeding, ureteral perforation, significant urothelial damage)
- •Suspicion of untreated urinary tract infection
- •History of pelvic radiation
- •Neurologic disease with a diagnosis of neurogenic bladder dysfunction
- •History of chronic pain (fibromyalgia, interstitial cystitis, opioid abuse)
研究组 & 干预措施
50 ml of 0.25% bupivacaine
干预措施: Bupivacaine (Drug)
placebo of 50 ml of Normal Saline
干预措施: Normal saline (Other)
结局指标
主要结局
Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
时间窗: At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Pain will be assessed using a Likert 10-point scale upon emergence from anesthesia in the recovery room, post-emergence 30 minutes, 60 minutes post-emergence and 6 and 24 hours post-emergence. These types of scales are commonly used to measure post operative pain both in anesthesia and in endourology
次要结局
- Time to discharge(From Baseline to post- operative day 5)
- Milliequivalent of morphine consumed(From Baseline to post- operative day 5)
- Number of bladder spasms(From Baseline to post- operative day 5)
- Time to void(From Baseline to post- operative day 5)
- Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)(From Baseline to post- operative day 5)
- The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form(From Baseline to post- operative day 5)
- Adverse events(From Baseline to post- operative day 5)