post-op acetaminophen vs nsaid use on lumbar spinal fusion outcomes

Conditions: Lumbar Osteoarthritis; Spondylosis; Lumbar Disc Disease; Spinal Stenosis

Summary: patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (percocet, norco, oxycodone, morphine, etc.) to control their pain postoperatively. the widespread use of opioids, however, is associated with a number of side effects. these include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects. the purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. a secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \[quicker ambulation with physical therapy (pt), earlier return to work, etc.\].

given the potential for non-steroidal anti inflammatory drugs (nsaids) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (iv) acetaminophen (group a) or iv ketorolac (group k) versus placebo (group p). the impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. the specific aims of this study are as follows: * specific aim 1: determine the impact of iv ketorolac or iv acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the opiate-related symptom distress scale (orsds) * specific aim 2: determine the impact of iv ketorolac or iv acetaminophen use on functional outcomes defined by return to work, oswestry disability index (odi) and the veterans rand-12 (vr-12) health survey the primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. the investigators hypothesize that patients in group a and group k will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in group p. the investigators hypothesize that patients in group a and group k will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.

Eligibility criteria:
inclusion criteria: * age 18-75 * require 1 or 2 level lumbar spinal fusion through posterior or lateral approach * no history of long term opioid use (daily or almost daily opioid use \> 2 weeks) and not on opiates at time of presentation to clinic exclusion criteria: * documented allergy to nsaids or acetaminophen * history of: peptic ulcer disease, congestive heart failure, chronic liver disease, elevated alanine aminotransferase (alt)/ aspartate aminotransferase (ast) greater than 1.5 times control, bleeding disorder, renal dysfunction (serum creatinine \> 1.5 mg/dl), glucocorticoid use within 1 month of surgery * current smokers (quite date \< 30 days ago) * revision for pseudarthrosis * patients who are unable to physically or mentally provide consent to the study procedures.

Keywords: iv acetaminophen iv ketorolac post-operative analgesia opioid use