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NCT05597878 · ClinicalTrials.gov registry record · Phase 2
Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT05597878: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT05597878 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05597878, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.
Primary Outcome
Mean pain scores for opioid and opioid-free groups on Day 0, Day 1, and follow-up appointment between Day 7-10 will be summarized using means and standard deviations. To test that the Day 1 pain levels are not significantly worse in the opioid-free group than in the opioid group, a two sample one sided t-test with a null value of 1.5 for the difference between groups (the non-inferiority margin) will be used. The change in pain from day 0 to days 1, and 7-10 will be compared both within and betw
Interventions
- DRUG Acetaminophen
- DRUG Ketamine
- DRUG Ketorolac
- DRUG Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 2 |
Why NCT05597878 stopped before completion
NCT05597878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 4 interventions - of which Acetaminophen is the first listed.
NCT05597878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05597878 about?
NCT05597878 is a clinical study titled "Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy". The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted...
What is the current status of trial NCT05597878?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2023-04-18. Estimated completion is 2026-02-26.
What interventions are being tested in trial NCT05597878?
The interventions under investigation include: Acetaminophen (DRUG), Ketamine (DRUG), Ketorolac (DRUG), Oxycodone (DRUG).
Who is sponsoring clinical trial NCT05597878?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05597878's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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