Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy

Thomas Jefferson University

Status: Unknown

Conditions: Pain

Treatments: Drug: oral acetaminophen; Drug: intravenous acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02067442

12D.685

Details and patient eligibility

About

Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Single level lumbar micro disk surgery
• Ages 18-65

Exclusion Criteria

• morbid obesity
• prior back surgery
• opioid tolerance
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups

oral acetaminophen

Active Comparator group

Description:

Patients in this arm of the study will receive oral acetaminophen and an IV placebo

Treatment:

Drug: oral acetaminophen

intravenous acetaminophen

Active Comparator group

Description:

Patients in this arm of the study will receive IV acetaminophen and an oral placebo

Treatment:

Drug: intravenous acetaminophen