Actively Recruiting

Phase 3
Age: 45Years +
MALE
NCT07427043

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

Age: 45Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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