NCT07427043 Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
| NCT ID | NCT07427043 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Opioid Consumption, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Timothy Clinton, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT07427043 clinical trial?
This trial is open to male participants only, aged 45 Years or older, studying Opioid Consumption, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07427043 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07427043 currently recruiting?
Yes, NCT07427043 is actively recruiting participants. Contact the research team at tclinton1@bwh.harvard.edu for enrollment information.
Where is the NCT07427043 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT07427043 clinical trial?
NCT07427043 is sponsored by Brigham and Women's Hospital. The principal investigator is Timothy Clinton, MD at Brigham and Women's Hospital. The trial plans to enroll 300 participants.