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

NCT03020875 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 166 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Self reported pain frequency and intensity at 24 hour postoperative intervals until patient is discharged, at 6 week and 6 month follow-up. The scale is scored on a 100 mm line, with 0 being no pain and 100 being worst pain imaginable.

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 finished NCT03020875 record still lists

NCT03020875 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (68% lower).

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

NCT03020875 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03020875's enrollment target sits among peer trials

166 489th of 2000 higher than 1,509 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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Source: ClinicalTrials.gov NCT03020875, the US trial registry maintained by the National Library of Medicine. NCT03020875 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.