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Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

RecruitingPhase 3

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway

Who can join

Ages 45 and older · Men

Full eligibility 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)

About the study

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.

What is being tested

Sponsor: Brigham and Women's Hospital · Participants: 300 · Started: Mar 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07427043

Locations in the U.S.

MassachusettsBrigham and Women's Faulkner Hospital, Boston
Brigham and Women's Hospital, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.