Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Recruiting
Phase 3
Interventional Study
Opioid Consumption, Postoperative
Multimodal Analgesia
Robotic Assisted Laparoscopic Surgery
Robotic Assisted Laparoscopic Radical Prostatectomy
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 300 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
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About This Trial
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…
Trial Locations
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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…
Contacts