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) ]
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