Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

NCT ID: NCT07203079

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oral Acetaminophen 1000mg

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

Group Type ACTIVE_COMPARATOR

Acetaminophen Oral Tablet

Intervention Type 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.

Placebo infusion

Intervention Type 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.

Intravenous Acetaminophen 1000mg

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

Group Type EXPERIMENTAL

placebo oral tablet

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Tylenol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Atman Desai

Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atman Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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82641

Identifier Type: -

Identifier Source: org_study_id

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