Clinical Trial: Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes

Brief 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 Summary:

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.


Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: Perioperative Opioid use [ Time Frame: Hospital stay (2-4 days) ]

Measure the impact of treatment on total opioid use during the hospital stay


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Opioid Use at 4-6 weeks [ Time Frame: 4-6 weeks ]
    Track total opioid use after discharge for the first 4-6 weeks
  • Opioid Use at 3 months [ Time Frame: 3 months ]
    Track total opioid use after discharge for the first 3 months; assess for continued opioid use
  • Numerical Pain rating scale [ Time Frame: 1 days and 3 days ]
    Validated pain scale; will be completed by patient
  • Blinding assesment [ Time Frame: 3 days ]
    Ask patients what group they thought they were assigned to
  • Pain satisfaction [ Time Frame: 3 days ]
    Ask patients if they were satisfied with their pain management (Likert scale)
  • Brief Pain Inventory [ Time Frame: 1 day and 3 days ]
    Validated pain scale; will be completed by patients
  • Opioid related side effects [ Time Frame: Hospital Stay (1-4 days) ]
    Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded
  • Opioid related symptom distress scale [ Time Frame: 1 day and 3 days ]
    Validated outcome instrument to assess opioid related distress
  • Perioperative Complications [ Time Frame: Hospital Stay (1-4 days) ]
    Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
  • Days to walk 50 ft with PT [ Time Frame: Hospital Stay (1-4 days) ]
  • Length of stay [ Time Frame: Hospital Stay (1-4 days) ]
    Will record date of discharge
  • Veterans Rand - 12 [ Time Frame: 3 month follow up ]
    Functional outcome measure at 3 months (global function)
  • Oswestry Disability Index [ Time Frame: 3 month follow up ]
    Functional outcome measure at 3 months (low back pain)
  • Return to work [ Time Frame: 3 month follow up ]
    Record return to work


Original Secondary Outcome: Same as current

Information By: Hospital for Special Surgery, New York

Dates:
Date Received: February 18, 2016
Date Started: March 2016
Date Completion: August 2019
Last Updated: February 27, 2017
Last Verified: March 2016