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NCT03020875 · ClinicalTrials.gov registry record · Phase 4

IV vs Oral Acetaminophen in Spine Fusion Perioperative Care

A Phase 4 study, sponsored by Hospital for Special Surgery, New York.

Completed
Registry status
Phase 4
Development phase
166
Enrollment target

NCT03020875 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 166 participants.

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The verdict

NCT03020875, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.

COMPLETED
Registry status
Phase 4
Development phase
166 participants
Enrollment target

Study Summary

The United States is currently experiencing an explosive opioid epidemic. In 2014 alone, 28,647 Americans died from an opioid associated overdose; the annual death toll has increased by over 300% since 2000. The epidemic poses a complex scenario for physicians administering treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to severe pain. In order to reduce the patients risk for long term opioid use and the associated side effects, physicians have begun shifting to multimodal analgesic approaches to treat postoperative pain. These approaches have been found to be similarly efficacious, while also reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus. This study proposes a multimodal analgesic approach, which the investigators believe will reduce short and long term opioid usage, the associated side effects, and the financial burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive pain management, however its use is limited by a high cost to perceived benefit ratio. Oral acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV option, and also often not feasible to utilize in the immediate post-operative period when patients are unable to safely swallow pills. The hypothesis of this investigation is to understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar spinal surgery will result in improved pain management in the perioperative period while decreasing opioid usage and related complications.

Interventions

  • DRUG Ofirmev
  • DRUG Per Os Acetaminophen

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2017-01
Est. Completion 2025-02-03
Phase Phase 4

What the Registry Record Tells You About NCT03020875

The ClinicalTrials.gov registry entry for NCT03020875 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ofirmev is the first listed.

NCT03020875 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03020875 about?

NCT03020875 is a clinical study titled "IV vs Oral Acetaminophen in Spine Fusion Perioperative Care". The United States is currently experiencing an explosive opioid epidemic. In 2014 alone, 28,647 Americans died from an opioid associated overdose; the annual death toll has increased by over 300% since 2000. The epidemic poses a complex scenario for physicians administering treatment for postoperati...

What is the current status of trial NCT03020875?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 166 participants. The study started on 2017-01. Estimated completion is 2025-02-03.

What interventions are being tested in trial NCT03020875?

The interventions under investigation include: Ofirmev (DRUG), Per Os Acetaminophen (DRUG).

Who is sponsoring clinical trial NCT03020875?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 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.