RecruitingRecruiting
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
NCT07427043 · Brigham and Women's Hospital
In plain English
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Official title
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
About this study
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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-01
Estimated completion: 2027-04-30
Last updated: 2026-05-22
Interventions
Drug: multimodal analgesia pathway with up-front small opioid prescriptionDrug: multimodal analgesia pathway without up-front small opioid prescriptionDrug: pre-implementation baseline including opioid
Primary outcomes
- • Post-discharge opioid consumption (MME) (1-2 weeks after surgery)
Sponsor
Brigham and Women's Hospital · other
Contacts & investigators
ContactTimothy Clinton, MD · contact · tclinton1@bwh.harvard.edu · 617-732-6384
InvestigatorTimothy Clinton, MD · principal_investigator, Brigham and Women's Hospital
All locations (2)
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Brigham and Women's Faulkner HospitalRecruiting
Boston, Massachusetts, United States