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NCT02280291 · ClinicalTrials.gov registry record · Phase 4
Single Shot Versus OnQ Pump in Extremity Fractures
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT02280291: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT02280291 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02280291, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.
Primary Outcome
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
Interventions
- DRUG Ankle SSB
- DRUG Ankle OnQ
- DRUG DR SSB
- DRUG DR OnQ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 4 |
What the finished NCT02280291 record still lists
NCT02280291 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Ankle SSB is the first listed.
NCT02280291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02280291 about?
NCT02280291 is a clinical study titled "Single Shot Versus OnQ Pump in Extremity Fractures". Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that conti...
What is the current status of trial NCT02280291?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2013-08. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT02280291?
The interventions under investigation include: Ankle SSB (DRUG), Ankle OnQ (DRUG), DR SSB (DRUG), DR OnQ (DRUG).
Who is sponsoring clinical trial NCT02280291?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02280291's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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