Actively Recruiting
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
Led by Brigham and Women's Hospital · Updated on 2026-05-22
300
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a multimodal analgesia discharge pathway to reduce automatic opioid prescribing after routine robotic-assisted laparoscopic prostatectomy (RALP) in men aged 45 and older. This phase 3, open-label, randomized study compares standard opioid prescribing practices with new opioid-free or limited-opioid discharge plans. The goal is to lower postoperative opioid use while maintaining safe and effective pain control, bowel function recovery, and overall quality of care. Participants are randomized into one of three groups: a pre-implementation baseline group receiving standard opioid care, a group receiving a multimodal analgesia plan without an automatic opioid prescription but with access to request opioids via a phone line, and a group receiving the multimodal plan plus a small upfront opioid prescription. All patients receive standardized multimodal analgesic therapy during and after surgery, with opioids used only as needed in the hospital recovery phase. During the study, participants will be counseled on pain management and monitored for opioid consumption 1 to 2 weeks after surgery. Researchers will also track bowel function recovery at 1 week, emergency department visits, postoperative phone calls within 30 days, and same-day discharge rates. The total participation duration varies by patient, with data collected to assess the safety and effectiveness of reducing opioid use after RALP.
CONDITIONS
Brief 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 greater than 1.3
- Allergy or contraindication to NSAIDs
- Regular opioid use or history of substance abuse prior to surgery
- Unable to provide own informed consent
- Major surgical complications requiring deviation from standard RALP procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of Surgery and immediate post-operative period
Participants undergo robotic-assisted laparoscopic prostatectomy (RALP) and receive multimodal analgesia with or without a small opioid prescription as part of the opioid-free discharge pathway.
Same-day surgery and recovery period
Duration - Up to 30 days after surgery
Participants are followed for post-discharge opioid use, pain management, and recovery outcomes.
Postoperative phone calls and visits as needed up to 30 days
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here