Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Condition: Lumbar Osteoarthritis; Spondylosis; Lumbar Disc Disease; Spinal Stenosis
MeSH terms: Spinal Stenosis; Spondylosis; Osteoarthritis, Spine
Study type: Interventional

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.].
    

Detailed description: 
      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.
    

Intervention name(s): Ketorolac; Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.; Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.; Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Other intervention name(s): Toradol; Tylenol, Ofirmev; Normal Saline
Intervention MeSH terms: Acetaminophen; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IV acetaminophen; IV Ketorolac; Post-operative analgesia; Opioid use