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NCT Number: NCT07203079

Oral Versus Intravenous Acetaminophen in Lumbar Spine 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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen Oral Tablet

Drug

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

Placebo oral tablet

Drug

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.

Acetaminophen infusion

Drug

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.

placebo infusion

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: After surgery until discharge, up to 10 days

  2. Time to first ambulation after surgery

    Time frame: After surgery until discharge, up to 10 days

  3. 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)

  4. 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.

  5. 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

  6. 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

  7. Number of participants with treatment-related skin rash

    Time frame: After surgery until discharge, up to 10 days, whichever is first

    Per clinician assessment

  8. 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)

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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