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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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 100 participants.

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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.

Interventions

  • DRUG Ankle SSB
  • DRUG Ankle OnQ
  • DRUG DR SSB
  • DRUG DR OnQ

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2013-08
Est. Completion 2018-12-13
Phase Phase 4

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT02280291

The ClinicalTrials.gov registry entry for NCT02280291 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Ankle SSB is the first listed.

NCT02280291 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.