Narcotic-Free Percutaneous Nephrolithotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Scores
研究概览
简要总结
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
详细描述
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
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
- Single (Investigator)
盲法说明
Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
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
- •Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access
排除标准
- •Pregnant women
- •History of chronic opioid abuse
- •Allergy, hypersensitivity, or other contraindication to NSAID usage such as
- •eGFR < 60 mL/min
- •Peptic ulcer disease or history of gastric bypass
- •Concurrent use of antiplatelet or anticoagulation therapy (including aspirin)
- •Thrombocytopenia
- •Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
- •Concomitant medications:
- •Other NSAIDs
- •Antiplatelet or anticoagulation medications
- •Probenecid
- •Pentoxifylline
- •Allergy, hypersensitivity, or other contraindication to opioids:
- •Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone
- •Respiratory depression
- •Patients with acute or severe bronchial asthma or hypercarbia
- •Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia
- •Patients with hepatic Impairment
- •Concomitant medications:
- •Monoamine Oxidase Inhibitors (MAOIs)
- •Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
- •Diagnosis of chronic pain disorder
- •Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury)
- •Pre-existing stent or nephrostomy tube
- •Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum)
- •Pulmonary disease
- •Liver disease
- •Seizure disorders
- •Subjects taking nephrotoxic medications
- •Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
研究组 & 干预措施
Opioid group
Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.
干预措施: 5mg Oxycodone, Q6 PRN (Drug)
NSAID
Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.
干预措施: 10mg Ketorolac, Q6 PRN (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Scores
时间窗: post-op day 5 and post-op day 10
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
次要结局
- Pill Count(post-op at day 10)
- Number of Participants Who Called the Office(post-op up to day 10)
- Number of Participants With Pain Related Visits(post-op up to day 10)
- Patient-related Outcome Survey (PROMIS) Scores(post-op at day 10)
研究者
Mantu Gupta
Professor of Urology
Icahn School of Medicine at Mount Sinai