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NCT07427043 · ClinicalTrials.gov registry record · Phase 3
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
A Phase 3 study of Prostate Cancer and Multimodal Analgesia, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT07427043 is a Phase 3 study of Prostate Cancer and Multimodal Analgesia that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 300 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (51% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT07427043, a Phase 3 study of Prostate Cancer and Multimodal Analgesia, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG multimodal analgesia pathway with up-front small opioid prescription
- DRUG multimodal analgesia pathway without up-front small opioid prescription
- DRUG pre-implementation baseline including opioid
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Brigham and Women's Faulkner Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07427043
The ClinicalTrials.gov registry entry for NCT07427043 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (51% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which multimodal analgesia pathway with up-front small opioid prescription is the first listed.
NCT07427043 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07427043 about?
NCT07427043 is a clinical study titled "Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)". 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...
What is the current status of trial NCT07427043?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2026-03-01. Estimated completion is 2027-04-30.
What conditions does trial NCT07427043 study?
This clinical trial studies the following conditions: Prostate Cancer, Multimodal Analgesia, Opioid Consumption, Postoperative, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy.
What interventions are being tested in trial NCT07427043?
The interventions under investigation include: multimodal analgesia pathway with up-front small opioid prescription (DRUG), multimodal analgesia pathway without up-front small opioid prescription (DRUG), pre-implementation baseline including opioid (DRUG).
Who is sponsoring clinical trial NCT07427043?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07427043 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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