Optimizing Pain Control in Transurethral Resection of the Prostate
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.
详细描述
In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Are identified as candidates for TURP
- •Are 18 years of age or greater
- •Are proficient in English
排除标准
- •Have filled an opioid prescription in the last 2 months
- •Have an allergy to a medication included in the protocol
- •Have a history of pelvic radiation
- •Have renal failure (Serum Cr > 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's
- •Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen
研究组 & 干预措施
Multi-modal group
The multi-modal group will receive the following regimen while inpatient:
- 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours
- Acetaminophen 1000mg every 8 hours standing
- Ibuprofen 600mg every 6 hours standing
- Oxycodone 5mg PO every 4 hours as needed pain
- Phenazopyridine 100mg TID as needed for urinary burning
- Senna 1 tab every 12 hours
- Miralax 17g powder once daily as needed for constipation
- Patient Education (Figures 2 & 3)
The multi-modal group will receive the following prescriptions on discharge:
- Acetaminophen 1000mg every 8 hours standing for two days then as needed - 30 tabs
- Ibuprofen 600mg every 8 hours standing for two days then as needed - 30 tabs
- Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs
- Senna 1 tab every 12 hours - 10 tabs
干预措施: Ibuprofen 600 mg (Drug)
Multi-modal group
The multi-modal group will receive the following regimen while inpatient:
- 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours
- Acetaminophen 1000mg every 8 hours standing
- Ibuprofen 600mg every 6 hours standing
- Oxycodone 5mg PO every 4 hours as needed pain
- Phenazopyridine 100mg TID as needed for urinary burning
- Senna 1 tab every 12 hours
- Miralax 17g powder once daily as needed for constipation
- Patient Education (Figures 2 & 3)
The multi-modal group will receive the following prescriptions on discharge:
- Acetaminophen 1000mg every 8 hours standing for two days then as needed - 30 tabs
- Ibuprofen 600mg every 8 hours standing for two days then as needed - 30 tabs
- Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs
- Senna 1 tab every 12 hours - 10 tabs
干预措施: Education (Behavioral)
结局指标
主要结局
Opioid Consumption
时间窗: PACU-72 hours
Total opioid utilization
Pain Scores
时间窗: PACU-72 hours
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
次要结局
- Presence of a foley catheter at discharge.(0-48hours)
- Presence of narcotic side effects(48 hours after discharge)
- Were there any post-operative complications(0-48 hours)
研究者
Una Lee
Principal Investigator and Attending urologist
Benaroya Research Institute