Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription, pre-implementation baseline including opioid.
- Who it may be relevant to
- Registry conditions: Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
Overview
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.
Interventions
- Drug multimodal analgesia pathway with up-front small opioid prescription
multimodal analgesia pathway including an up-front small opioid prescription - Drug multimodal analgesia pathway without up-front small opioid prescription
multimodal analgesia pathway without up-front small opioid prescription - Drug pre-implementation baseline including opioid
pre-implementation baseline including opioid
Primary outcome measures
- Post-discharge opioid consumption (MME) [Time frame: 1-2 weeks after surgery]
Secondary outcome measures (4)
- Return of bowel function [Time frame: 1 week]
- Emergency Department visits [Time frame: 30 days]
- Postoperative phone calls [Time frame: 30 days]
- Same-day discharge rate [Time frame: Day of Surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Brigham and Women's Faulkner Hospital — Boston
Identifiers
NCT: NCT07427043 · 2024P001667