Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Status
RECRUITING
Phase
PHASE3
Age
≥ 45 Years
Enrollments
300Conditions
Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate CancerDrugs
multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription, pre-implementation baseline including opioidSummary
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.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Timothy Clinton
- 617-732-6384
- [email protected]
Principal Investigator
- Timothy Clinton, MD
Status
- RECRUITING
Contact Person
- Timothy Clinton
- 617-732-6384
- [email protected]
Principal Investigator
- Timothy Clinton, MD
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 Plan
Pre-implementation historical baseline - Standard care prior to study intervention
ACTIVE_COMPARATOR
Standard care prior to study intervention
DRUG:
pre-implementation baseline including opioidDescription:
pre-implementation baseline including opioid
Post-implementation ROPES with multimodal analgesia pathway alone
ACTIVE_COMPARATOR
Educated on post-op pain management, multimodal analgesia scripts given but no pre-emptive opioid script (to obtain opioid after discharge patient must call phone line to request).
DRUG:
multimodal analgesia pathway without up-front small opioid prescriptionDescription:
multimodal analgesia pathway without up-front small opioid prescription
Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription
ACTIVE_COMPARATOR
Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script.
DRUG:
multimodal analgesia pathway with up-front small opioid prescriptionDescription:
multimodal analgesia pathway including an up-front small opioid prescription
Outcome Measures
Primary Outcome Measures
Post-discharge opioid consumption (MME)
Secondary Outcome Measures
Return of bowel function
Emergency Department visits
Postoperative phone calls
Same-day discharge rate
Timeline
Last Updated
May 22, 2026Start Date
February 23, 2026Today
October 1, 2026Completion Date ( Estimated )
April 30, 2027
Sponsors of this trial
Lead Sponsor
Brigham and Women's Hospital
RECRUITING 
≥ 18 Years