Friday, September 28, 2018 9:00 AM–10:00 AM best papers Friday: 150. Single-center, randomized controlled trial of intravenous versus oral acetaminophen administration in perioperative care of circumferential lumbar fusion: a comparative effectiveness study

Abstract

BACKGROUND CONTEXT The U.S. opioid epidemic has been declared a national public health emergency with the HHS, FDA, and CDC all taking steps to address the alarming rates of opioid addiction and abuse. Since 2000, the annual death toll from an opioid associated overdose has increased by over 300%. In an effort to reduce the amount of opioids, physicians have used alternative approaches, which have proven to not only be effective, but also reduce the side effects such as nausea, constipation, and addiction. IV acetaminophen has been shown to successfully accomplish the reduction in opioid use, however, it is an expensive alternative. Testing the efficacy of IV acetaminophen versus its oral formulation will likely modify future postoperative pain management regimens while also addressing its cost-effectiveness. PURPOSE The objective of the study is to prospectively evaluate clinical outcomes and determine the cost effectiveness of IV versus oral (PO) acetaminophen following lumbar circumferential spine surgery. STUDY DESIGN/SETTING A prospective, single center, randomized controlled trial. PATIENT SAMPLE Patients between the ages of 18-80 who underwent circumferential lumbar fusion surgery were included in the study. Patients had failed conservative management for more than 12 months. Patients were excluded if they had already undergone lumbar surgery at the index level(s), were diagnosed with osteoporosis, had dysphagia prohibiting oral administration, or had a history of substance abuse. OUTCOME MEASURES Outcome measures included opioid equivalence, length of hospital stay, VAS measurements, and Oswestry Disability Index (ODI) scores. METHODS Patients were randomized to either the IV or PO acetaminophen treatment groups. Preoperatively, patients completed a baseline analgesic regimen questionnaire, surveys including VAS, SF-12, and ODI, and were administered their first acetaminophen dose within three hours of first incision. Postoperatively, patients received seven subsequent doses of their assigned acetaminophen, with access to supplemental analgesics if needed. Analgesic usage and VAS scores were monitored until discharge. Surveys were completed at six weeks and six months follow up. RESULTS Postoperatively, the daily morphine equivalence taken by the IV acetaminophen group was 66% less than the oral acetaminophen group (p CONCLUSIONS In conjunction with an overall reduction in opioid usage, patient reported surveys indicate better improvement of pain management with the use of IV acetaminophen following circumferential lumbar spine surgery. Despite the large discrepancy between the two formulations in cost to perceived benefit ratio, by significantly reducing the opioid usage and, therefore, its costs due to associated side effects, that discrepancy becomes far less dramatic. Our findings suggest that IV acetaminophen is a safe and effective alternative to current opioid-based postoperative analgesic regimens with a promising answer to the national public health emergency plaguing communities across the U.S.