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Not yet recruiting NCT07203079

Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

Phase IV Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetaminophen Oral Tablet, placebo oral tablet, Acetaminophen infusion, Placebo infusion.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Length of Hospital Stay [Time frame: After surgery until discharge, up to 10 days]
  • Time to first ambulation after surgery [Time frame: 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]
  • Cumulative opioid consumption [Time frame: After surgery until discharge, up to 10 days]
  • Healthcare cost during admission [Time frame: After surgery until discharge, up to 10 days]
  • Number of participants with treatment-related hepatic toxicity [Time frame: postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours]
  • Number of participants with treatment-related skin rash [Time frame: After surgery until discharge, up to 10 days, whichever is first]
  • Change in Patient Global Assessment Scale Score [Time frame: postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours]
  • Time to first additional opioid medication dose [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT07203079 · 82641

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗