Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

Stanford University

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Acetaminophen infusion; Drug: Acetaminophen Oral Tablet; Drug: placebo oral tablet; Drug: Placebo infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07203079

82641

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Oral Acetaminophen 1000mg

Active Comparator group

Description:

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

Treatment:

Drug: Placebo infusion

Drug: Acetaminophen Oral Tablet

Intravenous Acetaminophen 1000mg

Experimental group

Description:

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

Treatment:

Drug: placebo oral tablet

Drug: Acetaminophen infusion