Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NCT07427043 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2024P001667
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid Consumption, Postoperative; Multimodal Analgesia; Robotic Assisted Laparoscopic Surgery; Robotic Assisted Laparoscopic Radical Prostatectomy; Prostate Cancer

Keywords

Multimodal Analgesia; Robotic Assisted Laparoscopic Radical Prostatectomy; Postoperative Opioid Consumption; Localized Prostate Cancer; Robotic Assisted Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Post-discharge opioid consumption (MME)

  assessed at post-operative visit

  1-2 weeks after surgery

Secondary Outcomes (4)

• Return of bowel function

  1 week

• Emergency Department visits

  30 days

• Postoperative phone calls

  30 days

• Same-day discharge rate

  Day of Surgery

Study Arms (3)

Pre-implementation historical baseline - Standard care prior to study intervention

ACTIVE COMPARATOR

Standard care prior to study intervention

Drug: pre-implementation baseline including opioid

Post-implementation ROPES with multimodal analgesia pathway alone

ACTIVE COMPARATOR

Educated on post-op pain management, multimodal analgesia scripts given but no pre-emptive opioid script (to obtain opioid after discharge patient must call phone line to request).

Drug: multimodal analgesia pathway without up-front small opioid prescription

Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription

ACTIVE COMPARATOR

Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script.

Drug: multimodal analgesia pathway with up-front small opioid prescription

Interventions

multimodal analgesia pathway with up-front small opioid prescription DRUG

multimodal analgesia pathway including an up-front small opioid prescription

Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription DRUG

multimodal analgesia pathway without up-front small opioid prescription

Post-implementation ROPES with multimodal analgesia pathway alone

pre-implementation baseline including opioid DRUG

pre-implementation baseline including opioid

Pre-implementation historical baseline - Standard care prior to study intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥45 years old
• Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
• Able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Timothy Clinton, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Clinton, MD

CONTACT

617-732-6384; tclinton1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)