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NCT Number: NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

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.

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Key information

Conditions

Opioid Consumption, Postoperative Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Multimodal Analgesia Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Robotic Assisted Laparoscopic Radical Prostatectomy Robotic Assisted Laparoscopic Surgery Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Brigham and Women's Faulkner Hospital, Boston, Massachusetts, United States

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About this study

The Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) study will implement and systematically evaluate an opioid-free discharge pathway (OFP) after robotic-assisted laparoscopic prostatectomy (RALP) at Brigham and Women's Hospital and Brigham & Women's Faulkner Hospital. Patients are counseled pre-operatively and offered participation. Data will be compared across three prospectively studied groups: pre-implementation historical baseline (current practice), post-implementation ROPES with multimodal analgesia pathway alone (which requires patients to call phone line after discharge to request opioid if pain uncontrolled), and post-implementation ROPES with multimodal analgesia pathway plus up-front small opioid prescription. Standardized multimodal analgesic therapy is provided to all participating patients following study implementation, with opioids used only as needed. There is no change to the surgery and anesthesia plan (though standard care at our center includes injection of local anesthetic to incisions and ketorolac is encouraged at end of the procedure), and patients are allowed opioids while admitted to the post-op recovery area. The study aims to reduce postoperative opioid use while maintaining safety and quality outcomes; this will assess non-inferiority of ROPES OFP in comparison to standard opioid prescribing. Results may inform wider practice change within both our center, the field of urology, and perhaps surgical care more broadly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

multimodal analgesia pathway with up-front small opioid prescription

Drug

multimodal analgesia pathway including an up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

Drug

multimodal analgesia pathway without up-front small opioid prescription

pre-implementation baseline including opioid

Drug

pre-implementation baseline including opioid

Primary outcomes

  1. Post-discharge opioid consumption (MME)

    Time frame: 1-2 weeks after surgery

    assessed at post-operative visit

Secondary outcomes

  1. Return of bowel function

    Time frame: 1 week

  2. Emergency Department visits

    Time frame: 30 days

  3. Postoperative phone calls

    Time frame: 30 days

  4. Same-day discharge rate

    Time frame: Day of Surgery

    Index hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy Clinton, MD

CONTACT

[email protected]

617-732-6384

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: ROPES

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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