NCT07427043RecruitingPhase 3
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07427043
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Mar 2026 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular opioid use or substance abuse prior to surgery
- 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)
Other illness
- Chronic kidney disease (baseline Cr \>1.3)
- NSAID contraindication/allergy
Other
- Inability to provide their own consent
Who the study is looking for
- Men ≥45 years old
- Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- Able to provide informed consent
Age in the registry: 45 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Faulkner Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.