Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

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: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Acetaminophen Oral Tablet; Drug: Placebo infusion; Drug: placebo oral tablet; Drug: Acetaminophen infusion

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Pain Intensity Scale Score	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

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay		After surgery until discharge, up to 10 days
Time to first ambulation after surgery		After surgery until discharge, up to 10 days
Cumulative opioid consumption	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	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	Per clinician assessment	After surgery until discharge, up to 10 days, whichever is first
Time to first additional opioid medication dose	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	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	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	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	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

• Sponsor: Stanford University
• Investigators: Principal Investigator: Atman Desai, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Estimated): October 2, 2025

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen
• Other Study ID 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