RecruitingPhase 3NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway


Sponsor

Brigham and Women's Hospital

Enrollment

300 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 45 Years

Inclusion Criteria3

  • Men ≥45 years old
  • Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
  • Able to provide informed consent

Exclusion Criteria5

  • 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)

Interventions

DRUGmultimodal analgesia pathway with up-front small opioid prescription

multimodal analgesia pathway including an up-front small opioid prescription

DRUGmultimodal analgesia pathway without up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

DRUGpre-implementation baseline including opioid

pre-implementation baseline including opioid


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

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NCT07427043


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