Trial intelligence / Profile preview

Oral vs IV Acetaminophen in Lumbar Spine Fusion

NCT07203079Phase 4

Key facts

Status: Not yet recruiting
Start: Jan 2026
Primary completion: Oct 2026
Countries: 1
Sponsor: Stanford University
Modality: Small Molecules

Drugs: acetaminophen
Conditions: postoperative pain

Overview

Phase 4, randomised, double-blind trial of acetaminophen in postoperative pain (2 arms), sponsored by Stanford University. Primary endpoint: Numerical Rating Scale Pain Intensity Scale Score at 48 hours. Planned start Jan 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Oral Acetaminophen
Oral Acetaminophen 1000mg + Placebo IV every 6 hours
IV Acetaminophen
IV Acetaminophen 1000mg + Placebo Oral every 6 hours

Who it enrols

Adult patients planning for open lumbar laminectomy and fusion surgery (1-3 levels) who can swallow pills. Excludes patients with contraindications to acetaminophen, emergency surgery, or chronic pain unrelated to surgery.

Endpoints

Primary

Numerical Rating Scale Pain Intensity Scale Score48 hours

Secondary

Length of Hospital StayUp to 10 days
Time to first ambulation after surgeryUp to 10 days
Quality of Life (EuroQol Questionaire) scale score1 month
Cumulative opioid consumptionUp to 10 days
Healthcare cost during admissionUp to 10 days
Number of participants with treatment-related hepatic toxicity48 hours
Number of participants with treatment-related skin rashUp to 10 days
Change in Patient Global Assessment Scale Score48 hours

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