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RECRUITING
NCT07427043
PHASE3

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03-01

Completion Date

2027-04-30

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

multimodal analgesia pathway with up-front small opioid prescription

multimodal analgesia pathway including an up-front small opioid prescription

DRUG

multimodal analgesia pathway without up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

DRUG

pre-implementation baseline including opioid

pre-implementation baseline including opioid

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States