NCT07203079

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

September 24, 2025

Last Update Submit

October 3, 2025

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • Quality of Life (EuroQol Questionaire) scale score

    48 hours, up to 1 month after surgery

  • Cumulative opioid consumption

    After surgery until discharge, up to 10 days

  • Healthcare cost during admission

    After surgery until discharge, up to 10 days

  • +5 more secondary outcomes

Study Arms (2)

Oral Acetaminophen 1000mg

ACTIVE COMPARATOR

Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery

Drug: Acetaminophen Oral TabletDrug: Placebo infusion

Intravenous Acetaminophen 1000mg

EXPERIMENTAL

Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery

Drug: placebo oral tabletDrug: Acetaminophen infusion

Interventions

Acetaminophen Oral TabletDRUG

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.

Also known as: Tylenol
Oral Acetaminophen 1000mg
placebo oral tabletDRUG

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.

Intravenous Acetaminophen 1000mg
Acetaminophen infusionDRUG

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.

Intravenous Acetaminophen 1000mg
Placebo infusionDRUG

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.

Oral Acetaminophen 1000mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Atman Desai, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)