NCT07427043

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	multimodal analgesia pathway with up-front small opioid prescription	multimodal analgesia pathway including an up-front small opioid prescription
DRUG	multimodal analgesia pathway without up-front small opioid prescription	multimodal analgesia pathway without up-front small opioid prescription
DRUG	pre-implementation baseline including opioid	pre-implementation baseline including opioid

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2027-04-30
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study