Actively Recruiting
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Led by Brigham and Women's Hospital · Updated on 2026-02-23
300
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 45 years old or older
- Scheduled for Robotic Assisted Laparoscopic Prostatectomy (RALP) at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital
- Able to provide informed consent
You will not qualify if you...
- Chronic kidney disease with baseline creatinine over 1.3
- Allergy or contraindication to NSAIDs
- Regular opioid use or substance abuse prior to surgery
- Unable to provide own consent
- Major surgical complications altering standard RALP procedure requiring operative intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Actively Recruiting
Research Team
T
Timothy Clinton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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