Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) (ROPES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Multimodal Analgesia; Robotic Assisted Laparoscopic Surgery; Opioid Consumption, Postoperative; Robotic Assisted Laparoscopic Radical Prostatectomy
• Intervention / Treatment: Drug: pre-implementation baseline including opioid; Drug: multimodal analgesia pathway without up-front small opioid prescription; Drug: multimodal analgesia pathway with up-front small opioid prescription

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Timothy Clinton, MD; Phone Number: 617-732-6384; Email: tclinton1@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Timothy Clinton; Phone Number: 617-732-6384; Email: tclinton1@bwh.harvard.edu
    • Boston, Massachusetts, United States, 02130
      • Recruiting
      • Brigham and Women's Faulkner Hospital
      • Contact: Timothy Clinton; Phone Number: 617-732-6384; Email: tclinton1@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-implementation historical baseline - Standard care prior to study intervention; Standard care prior to study intervention	Drug: pre-implementation baseline including opioid; pre-implementation baseline including opioid
Active Comparator: Post-implementation ROPES with multimodal analgesia pathway alone; 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; multimodal analgesia pathway without up-front small opioid prescription
Active Comparator: Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription; 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; multimodal analgesia pathway including an up-front small opioid prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge opioid consumption (MME)	assessed at post-operative visit	1-2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of bowel function		1 week
Emergency Department visits		30 days
Postoperative phone calls		30 days
Same-day discharge rate	Index hospitalization	Day of Surgery

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Timothy Clinton, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Opioid Consumption; Localized Prostate Cancer; Robotic Assisted Laparoscopic Surgery; Multimodal Analgesia; Robotic Assisted Laparoscopic Radical Prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024P001667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This trial is being performed at within a single institution (Mass General Brigham) at two of it's constituent sites (BWH and BWFH), as part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutions system and any IPD would be solely stored on HIPAA compliant servers at the facility. De=identified or aggregated data would be permitted to be shared so long as subjects could not be identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No