Opioid-Free Pain Management for Prostate Cancer Surgery
(ROPES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to manage pain without opioids after prostate cancer surgery. It tests two pain control plans: one provides a small amount of opioids upfront, while the other offers opioids only upon patient request. The study will compare these plans to the standard care used before the trial began. Men undergoing robotic surgery for prostate cancer who can provide their own consent may be suitable candidates, particularly if they do not regularly use opioids or have kidney disease. This approach is part of the Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES). As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking pain management strategy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that treatments like ketamine, ketorolac, and acetaminophen, which are being tested in this trial, are generally safe for people. Research has focused on reducing the need for opioids after surgery while still effectively managing pain. The goal is to keep patients comfortable without the risks of opioids, such as addiction or side effects. Although this trial is still collecting new information, past studies suggest these treatments are well-tolerated and safe for managing pain after prostate surgery.12345
Why are researchers excited about this trial?
Researchers are excited about the Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) because it offers an innovative approach to managing pain without relying heavily on opioids. Unlike traditional methods that often involve significant opioid use, this strategy uses a multimodal analgesia pathway to manage pain, minimizing the risk of opioid dependency. One arm of the trial even explores a method where patients are educated on post-op pain management and can request opioids only if necessary, further reducing exposure. This approach not only aims to effectively control pain but also addresses the growing concern about opioid addiction and side effects, making it a potentially safer alternative for patients undergoing prostate cancer surgery.
What evidence suggests that this trial's treatments could be effective for pain management in prostate cancer surgery?
Research has shown that the Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) effectively reduces the need for opioids after prostate cancer surgery. In this trial, participants will be divided into different arms to evaluate ROPES's effectiveness. One arm will receive the multimodal analgesia pathway with an up-front small opioid prescription, while another will receive the multimodal analgesia pathway alone, requiring patients to request opioids post-discharge if needed. Studies have found that combining different pain relief methods leads to better pain control after surgery. Specifically, patients undergoing robotic-assisted prostate surgery with this approach report less pain and faster recovery. This strategy also reduces side effects linked to opioid use, such as constipation and nausea. By focusing on pain management without opioids, ROPES aims to reduce opioid use and support quicker recovery of bowel function and fewer unexpected healthcare visits.13678
Who Is on the Research Team?
Timothy Clinton, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Counseling
Patients are counseled on post-operative pain management and offered participation in the study
Surgery and Immediate Post-op
Robotic-assisted laparoscopic prostatectomy performed with standard care including local anesthetic and ketorolac; opioids allowed in post-op recovery area
Post-operative Discharge Pathway
Implementation of multimodal analgesia discharge pathway with or without up-front opioid prescription
Follow-up
Participants are monitored for postoperative opioid consumption and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
How Is the Trial Designed?
3
Treatment groups
Active Control
Standard care prior to study intervention
Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
Robotic Opioid-free Prostatectomy Enhanced Strategy ...
Data will be compared across three prospectively studied groups: pre-implementation historical baseline (current practice), post-implementation ROPES with ...
Robotic Opioid-free Prostatectomy Enhanced Strategy ...
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway ...
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including ...
Robot-assisted radical prostatectomy: Advancements in ... - PMC
We reviewed the evolving strategies, practice patterns, and recent advancements aimed at improving the perioperative and surgical outcomes in patients ...
Better post-op pain outcomes seen with robotic RP
Better post-op pain outcomes seen with robotic RP. A study comparing postoperative pain between robot-assisted laparoscopic radical prostatectomy (RALP) and ...
Robotic Opioid-free Prostatectomy Enhanced Strategy ...
The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including ...
Intravenous Lidocaine for Postoperative Pain and Recovery ...
This study investigated the impact of intravenous lidocaine on postoperative pain, opioid consumption, and recovery outcomes in patients ...
Preemptive versus preventive intravenous acetaminophen ...
Introduction. Robot-assisted radical prostatectomy (RALP) is widely performed for localized prostate cancer within enhanced recovery pathways.
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