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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?

Pain

Study Interventions

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

Study Arms

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

Study Status

Unknown status

Start Date: August 2013

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Postoperative pain scores

Secondary Outcome: Quantity of intraoperative and postoperative opioids administered.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Thomas Jefferson University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02067442

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