ROPES: an opioid-free discharge approach for robotic prostatectomy
Official title: Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
Run by Brigham and Women's Hospital · NCT07427043 · Data updated 2026-11-12
We are testing whether a standardized multimodal pain plan without an automatic opioid prescription helps men having robotic-assisted prostate removal use fewer opioids after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years and up |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07427043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 45 or older undergoing robotic-assisted laparoscopic radical prostatectomy at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital who can give informed consent and are not on regular opioids or otherwise excluded.
✕Probably not a fit
Patients who use opioids regularly before surgery, have significant kidney disease, have contraindications to NSAIDs, cannot consent, or require non-routine/complicated surgery are unlikely to benefit from this pathway.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label Phase 3 study compares three groups: a historical pre-implementation baseline, a post-implementation multimodal analgesia pathway that requires patients to call to request opioids, and a post-implementation pathway that provides a small opioid prescription up front. All post-implementation patients receive standardized multimodal analgesia around the time of surgery, with opioids available as needed in the immediate recovery period. The primary outcome is postoperative opioid consumption, and secondary outcomes include bowel function recovery, unplanned care visits or phone calls, and same-day discharge rates. The goal is to determine whether an opioid-free discharge pathway can safely reduce opioid use after robotic-assisted laparoscopic radical prostatectomy.
Why it matters
Potential benefit: If successful, the approach could substantially reduce unnecessary opioid prescriptions and opioid use after robotic prostatectomy while maintaining safe pain control.
How similar studies have gone: Other opioid-sparing and multimodal analgesia programs have reduced opioid prescribing and use after various surgeries, but randomized Phase 3 evidence specifically for robotic prostatectomy is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Timothy Clinton, MD — Brigham and Women's Hospital
- Study coordinator: Timothy Clinton, MD
- Email: tclinton1@bwh.harvard.edu
- Phone: 617-732-6384
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.