Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Purpose
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
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Sex
- Male
- Accepts 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)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Pre-implementation historical baseline - Standard care prior to study intervention |
Standard care prior to study intervention |
|
|
Active Comparator Post-implementation ROPES with multimodal analgesia pathway alone |
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). |
|
|
Active Comparator Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription |
Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script. |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02130
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.