Pain | Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy
Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Single level lumbar micro disk surgery - Ages 18-65 Exclusion Criteria - morbid obesity - prior back surgery - opioid tolerance - pregnancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oral acetaminophen1000 milligrams given orally before surgery
Drug:intravenous acetaminophen1000 milligrams of intravenous acetaminophen given before surgery
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
oral acetaminophenPatients in this arm of the study will receive oral acetaminophen and an IV placebo
intravenous acetaminophenPatients in this arm of the study will receive IV acetaminophen and an oral placebo
Start Date: August 2013
Primary Outcome: Postoperative pain scores
Secondary Outcome: Quantity of intraoperative and postoperative opioids administered.
Study sponsors, principal investigator, and references
Lead Sponsor: Thomas Jefferson University