Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age45+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Men ≥45 years old

Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH

Able to provide informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • multimodal analgesia pathway with up-front small opioid prescription
  • multimodal analgesia pathway without up-front small opioid prescription
  • pre-implementation baseline including opioid

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators