Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Eligible age
45+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ Men ≥45 years old
- ✓ Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- ✓ Able to provide informed consent
You may not qualify if…
- ✕ 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)
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT07427043 · last updated 2026-05-22