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Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

RecruitingPhase 3Ages 45 Years - anyMaleBrigham and Women's Hospital
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In plain words

What the trial is, and whether it could suit you

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 po

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Men โ‰ฅ45 years old * Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH * Able to provide informed consent Exclusion Criteria: * 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)
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What it tests

  • multimodal analgesia pathway with up-front small opioid prescription
  • multimodal analgesia pathway without up-front small opioid prescription
  • pre-implementation baseline including opioid
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Where

2 sites
Brigham and Women's Hospital
Boston, United States
Brigham and Women's Faulkner Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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