Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount of medication used
研究概览
简要总结
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
详细描述
This study will conduct a randomized control double-blind clinical trial to evaluate an opioid versus a non-opioid pathway of gabapentin, ketorolac, and acetaminophen in treating postoperative pain following robot-assisted radical prostatectomy (RARP).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (RARP) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer
排除标准
- •Allergies to any medication involved in the study
- •T4 prostate cancer
- •incarcerated persons
- •chronic narcotic dependence
- •any current prescription for narcotics
- •any surgery in the past 6 months
研究组 & 干预措施
Opioid Control Cohort
One treatment selected:
Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
干预措施: Tramadol (Drug)
Opioid Control Cohort
One treatment selected:
Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
干预措施: Hydrocodone-Acetaminophen (Drug)
Opioid Control Cohort
One treatment selected:
Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
干预措施: Oxycodone-Acetaminophen (Drug)
Experimental Cohort
Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
干预措施: Gabapentin (Drug)
Experimental Cohort
Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
干预措施: Ketorolac (Drug)
Experimental Cohort
Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
干预措施: Acetaminophen (Drug)
Experimental Cohort
Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
干预措施: Ketorolac tromethamine (Drug)
Experimental Cohort
Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
干预措施: Ketamine (Drug)
结局指标
主要结局
Amount of medication used
时间窗: Time of Discharge postoperative up to Day 3
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Visual Analogue Pain Score
时间窗: Day 7
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Opioid-Related Symptom Distress Scale (ORSDS)
时间窗: Day 7
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
次要结局
未报告次要终点