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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Faulkner Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.