Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

October 3, 2025 updated by: Atman Desai, Stanford University

A Randomized, Double-Blind, Placebo-Controlled Trial Comparing 48-Hour Post-Operative Administration of Oral Versus Intravenous Acetaminophen in Patients Undergoing Lumbar Spine Fusion Surgery

The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Plan for open lumbar laminectomy and fusion surgery (1-3 levels)
  • Able to provide written informed consent
  • Must be able to swallow pills

Exclusion Criteria:

  • Medical contraindications to acetaminophen
  • Emergency surgery
  • Chronic pain unrelated to surgery
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oral Acetaminophen 1000mg
Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery
Drug: Acetaminophen Oral Tablet
Participants take 1000mg by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Other Names:
  • Tylenol
Drug: Placebo infusion
Participants take 1000mg placebo by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Experimental: Intravenous Acetaminophen 1000mg
Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery
Drug: placebo oral tablet
Participants take one placebo tablet (matchable to tylenol) by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Drug: Acetaminophen infusion
Participants take 1000mg by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) Pain Intensity Scale Score
Time Frame: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Mean pain intensity scores post-operatively using 11-point Numerical Rating Scale (NRS) (scale ranges from 0 to 10, and higher score means higher pain)
postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: After surgery until discharge, up to 10 days
After surgery until discharge, up to 10 days
Time to first ambulation after surgery
Time Frame: After surgery until discharge, up to 10 days
After surgery until discharge, up to 10 days
Cumulative opioid consumption
Time Frame: After surgery until discharge, up to 10 days
All opioid medications the patient takes after surgery will be converted to a morphine equivalent dose.
After surgery until discharge, up to 10 days
Healthcare cost during admission
Time Frame: After surgery until discharge, up to 10 days
Cost of hospital stay obtained from participant's Electronic Medical Record
After surgery until discharge, up to 10 days
Number of participants with treatment-related skin rash
Time Frame: After surgery until discharge, up to 10 days, whichever is first
Per clinician assessment
After surgery until discharge, up to 10 days, whichever is first
Time to first additional opioid medication dose
Time Frame: After surgery until discharge, up to 10 days
Additional opioid pain medication as requested by the participant which is not scheduled
After surgery until discharge, up to 10 days
Total number of additional opioid medication doses
Time Frame: After surgery until discharge, up to 10 days
Additional opioid pain medication as requested by the participant which is not scheduled
After surgery until discharge, up to 10 days
Quality of Life (EuroQol Questionaire) scale score
Time Frame: 48 hours, up to 1 month after surgery
Participants rate their quality of life using the EuroQol-5D-5L questionnaire (scale from 1 to 5, 1 = no problem, 5 = severe problem)
48 hours, up to 1 month after surgery
Number of participants with treatment-related hepatic toxicity
Time Frame: postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours
Values above the normal range for any of these four lab tests (AST, ALT, INR, bilirubin) will be considered hepatic toxicity
postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours
Change in Patient Global Assessment Scale Score
Time Frame: postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Participants report their overall wellbeing as measured by 5-point Likert scale (ranging from 0-5, where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor)
postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Atman Desai, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 82641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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