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IV vs Oral Acetaminophen in Spine Fusion Perioperative Care

NCT03020875 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2026-04-28

No results posted yet for this 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.

Conditions

  • Multimodal Analgesic Approach

Interventions

DRUG

Ofirmev

Intravenously administered acetaminophen.

DRUG

Per Os Acetaminophen

Orally administered acetaminophen.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Chad Craig, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2025-02-03
Completion
2025-02-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020875 on ClinicalTrials.gov