Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
Brigham and Women's Hospital
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.
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 t…
Eligibility
- Age range
- 45+ years
- Sex
- Male
- Healthy volunteers
- No
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)
Interventions
- Drugmultimodal analgesia pathway with up-front small opioid prescription
multimodal analgesia pathway including an up-front small opioid prescription
- Drugmultimodal analgesia pathway without up-front small opioid prescription
multimodal analgesia pathway without up-front small opioid prescription
- Drugpre-implementation baseline including opioid
pre-implementation baseline including opioid
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Brigham and Women's Faulkner HospitalBoston, Massachusetts