Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Recruiting now · Phase 3
Conditions studied: Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT07427043
- Run by
- Brigham and Women's Hospital
- People needed
- 300
- Starts
- 2026-03-01
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-05-22
Who can join
Age: 45 and older. Sex: male. Healthy volunteers: not accepted.
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 is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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