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Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Study acronym: ROPES
StatusRecruiting
PhasePhase 3
Started2026-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-20
minor
Study Status v1
Re-verified, no change to tracked fields
2026-02-16
minor
Original filing
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.
Trial Details
NCT Number NCT07427043
Lead Sponsor Brigham and Women's Hospital
Conditions Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate Cancer
Enrollment 300 participants
Start Date 2026-03-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22