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Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

RECRUITINGPhase 3Sponsored by Brigham and Women's Hospital
Actively Recruiting
PhasePhase 3
SponsorBrigham and Women's Hospital
Started2026-03-01
Est. completion2026-12-31
Eligibility
Age45 Years+
SexMALE
Healthy vol.Accepted
Locations2 sites

Summary

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.

Eligibility

Age: 45 Years+Sex: MALEHealthy volunteers accepted
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)

Conditions6

CancerMultimodal AnalgesiaOpioid Consumption, PostoperativeProstate CancerRobotic Assisted Laparoscopic Radical ProstatectomyRobotic Assisted Laparoscopic Surgery

Locations2 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Timothy Clinton617-732-6384tclinton1@bwh.harvard.edu
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Timothy Clinton617-732-6384tclinton1@bwh.harvard.edu

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