Actively Recruiting

Phase 3
Age: 45Years +
MALE
ID07427043

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

Led by Brigham and Women's Hospital · Updated on 2026-05-22

300

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a multimodal analgesia discharge pathway to reduce automatic opioid prescribing after routine robotic-assisted laparoscopic prostatectomy (RALP) in men aged 45 and older. This phase 3, open-label, randomized study compares standard opioid prescribing practices with new opioid-free or limited-opioid discharge plans. The goal is to lower postoperative opioid use while maintaining safe and effective pain control, bowel function recovery, and overall quality of care. Participants are randomized into one of three groups: a pre-implementation baseline group receiving standard opioid care, a group receiving a multimodal analgesia plan without an automatic opioid prescription but with access to request opioids via a phone line, and a group receiving the multimodal plan plus a small upfront opioid prescription. All patients receive standardized multimodal analgesic therapy during and after surgery, with opioids used only as needed in the hospital recovery phase. During the study, participants will be counseled on pain management and monitored for opioid consumption 1 to 2 weeks after surgery. Researchers will also track bowel function recovery at 1 week, emergency department visits, postoperative phone calls within 30 days, and same-day discharge rates. The total participation duration varies by patient, with data collected to assess the safety and effectiveness of reducing opioid use after RALP.

CONDITIONS

Brief 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 greater than 1.3
  • Allergy or contraindication to NSAIDs
  • Regular opioid use or history of substance abuse prior to surgery
  • Unable to provide own informed consent
  • Major surgical complications requiring deviation from standard RALP procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of Surgery and immediate post-operative period

Participants undergo robotic-assisted laparoscopic prostatectomy (RALP) and receive multimodal analgesia with or without a small opioid prescription as part of the opioid-free discharge pathway.

Same-day surgery and recovery period

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are followed for post-discharge opioid use, pain management, and recovery outcomes.

Postoperative phone calls and visits as needed up to 30 days

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

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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