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

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ClinicalTrials.gov Identifier: NCT02067442
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : February 20, 2014
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: oral acetaminophen Drug: intravenous acetaminophen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy
Study Start Date : August 2013
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Ofirmev




Primary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: Day of surgery ]
    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.


Secondary Outcome Measures :
  1. Quantity of intraoperative and postoperative opioids administered. [ Time Frame: Day of surgery ]
    All doses of opioids given on the day of surgery will be recorded.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067442


Contacts
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Contact: Marc D Fisicaro, MD 215-955-6161 marc.fisicaro@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hopsital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marc Fisicaro, MD       marc.fisicaro@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02067442     History of Changes
Other Study ID Numbers: 12D.685
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Thomas Jefferson University:
acetaminophen intravenous oral pain scores opioids
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics