Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Post-discharge opioid consumption (MME)
研究概览
简要总结
This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.
详细描述
The Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) study will implement and systematically evaluate an opioid-free discharge pathway (OFP) after robotic-assisted laparoscopic prostatectomy (RALP) at Brigham and Women's Hospital and Brigham & Women's Faulkner Hospital. Patients are counseled pre-operatively and offered participation. Data will be compared across three prospectively studied groups: pre-implementation historical baseline (current practice), post-implementation ROPES with multimodal analgesia pathway alone (which requires patients to call phone line after discharge to request opioid if pain uncontrolled), and post-implementation ROPES with multimodal analgesia pathway plus up-front small opioid prescription. Standardized multimodal analgesic therapy is provided to all participating patients following study implementation, with opioids used only as needed. There is no change to the surgery and anesthesia plan (though standard care at our center includes injection of local anesthetic to incisions and ketorolac is encouraged at end of the procedure), and patients are allowed opioids while admitted to the post-op recovery area. The study aims to reduce postoperative opioid use while maintaining safety and quality outcomes; this will assess non-inferiority of ROPES OFP in comparison to standard opioid prescribing. Results may inform wider practice change within both our center, the field of urology, and perhaps surgical care more broadly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥45 years old
- •Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- •Able to provide informed consent
排除标准
- •Chronic kidney disease (baseline Cr >1.3)
- •NSAID contraindication/allergy
- •Regular opioid use or substance abuse prior to surgery
- •Inability to provide their own consent
- •Deviation from standard surgical practice for RALP (e.g. major complication requiring operative intervention that would result in patient no longer being considered a routine case)
研究组 & 干预措施
Pre-implementation historical baseline - Standard care prior to study intervention
Standard care prior to study intervention
干预措施: pre-implementation baseline including opioid (Drug)
Post-implementation ROPES with multimodal analgesia pathway alone
Educated on post-op pain management, multimodal analgesia scripts given but no pre-emptive opioid script (to obtain opioid after discharge patient must call phone line to request).
干预措施: multimodal analgesia pathway without up-front small opioid prescription (Drug)
Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription
Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script.
干预措施: multimodal analgesia pathway with up-front small opioid prescription (Drug)
结局指标
主要结局
Post-discharge opioid consumption (MME)
时间窗: 1-2 weeks after surgery
assessed at post-operative visit
次要结局
- Return of bowel function(1 week)
- Emergency Department visits(30 days)
- Postoperative phone calls(30 days)
- Same-day discharge rate(Day of Surgery)
研究者
Timothy Clinton
Associate Surgeon
Brigham and Women's Hospital