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

Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: oral acetaminophen; Drug: intravenous acetaminophen

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc D Fisicaro, MD; Phone Number: 215-955-6161; Email: marc.fisicaro@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hopsital
      • Contact: Marc Fisicaro, MD; Email: marc.fisicaro@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oral acetaminophen; Patients in this arm of the study will receive oral acetaminophen and an IV placebo	Drug: oral acetaminophen; 1000 milligrams given orally before surgery; Other Names: Tylenol
Active Comparator: intravenous acetaminophen; Patients in this arm of the study will receive IV acetaminophen and an oral placebo	Drug: intravenous acetaminophen; 1000 milligrams of intravenous acetaminophen given before surgery; Other Names: Ofirmev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain scores	Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery.	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of intraoperative and postoperative opioids administered.	All doses of opioids given on the day of surgery will be recorded.	Day of surgery

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: acetaminophen intravenous oral pain scores opioids
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 12D.685