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Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NCT07427043 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Timothy Clinton, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07427043 on ClinicalTrials.gov