Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

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.

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