RecruitingPhase 3NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

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


Sponsor

Brigham and Women's Hospital

Enrollment

300 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study (ROPES) is testing an opioid-free pain management approach for men having robotic prostate removal surgery. Researchers want to find out whether it is possible to manage pain effectively after this procedure without using opioid painkillers, which carry risks of dependence and side effects. **You may be eligible if...** - You are a man aged 45 or older - You are scheduled for robotic-assisted laparoscopic prostatectomy (robotic prostate removal surgery) at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital - You are able to provide informed consent **You may NOT be eligible if...** - You have chronic kidney disease (creatinine above 1.3) - You have an allergy or contraindication to anti-inflammatory drugs (NSAIDs) - You use opioid medications regularly or have a history of substance misuse - You are unable to provide your own consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGmultimodal analgesia pathway with up-front small opioid prescription

multimodal analgesia pathway including an up-front small opioid prescription

DRUGmultimodal analgesia pathway without up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

DRUGpre-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07427043


Related Trials