Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Recruiting · NCT07427043 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Men ≥45 years old
- Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- Able to provide informed consent
Exclusion criteria
- 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
2 locations listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Brigham and Women's Faulkner Hospital - Boston, Massachusetts, United States