Clinical trial NCT02700451: Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Official title: A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Osteoarthritis
Spondylosis
Lumbar Disc Disease
Spinal Stenosis
Keywords: IV acetaminophen
IV Ketorolac
Post-operative analgesia
Opioid use
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Perioperative Opioid Use
timeFrame: Hospital stay (2-4 days)
Secondary outcomes:
measure: Opioid Use at 4-6 Weeks
timeFrame: 4-6 weeks
measure: Opioid Use at 3 Months
timeFrame: 3 months
measure: Opioid Use at 1 Year
timeFrame: 1 year
measure: Opioid Use at 2 Years
timeFrame: 2 years
measure: Numerical Pain Rating Scale
timeFrame: 1 days and 3 days
measure: Brief Pain Inventory
timeFrame: 1 day and 3 days
measure: Opioid Related Side Effects
timeFrame: Hospital Stay (1-4 days)
measure: Perioperative Complications - Drain Output
timeFrame: Hospital Stay (1-4 days)
measure: Perioperative Complications - Transfusion Rate
timeFrame: Hospital Stay (1-4 days)
measure: Days to Walk 50 ft With PT
timeFrame: Hospital Stay (1-4 days)
measure: Length of Stay
timeFrame: Hospital Stay (1-4 days)
measure: Veterans Rand - 12
timeFrame: pre-operative
measure: Oswestry Disability Index
timeFrame: pre-operative
measure: Veterans Rand - 12
timeFrame: 3 month follow up
measure: Oswestry Disability Index
timeFrame: 3 month follow up
measure: Return to Work
timeFrame: 3 month follow up
measure: Veterans Rand - 12
timeFrame: 1 year follow up
measure: Oswestry Disability Index
timeFrame: 1 year follow up
measure: Return to Work
timeFrame: 1 year follow up
measure: Numerical Pain Rating Scale
timeFrame: 1 year follow up
measure: Veterans Rand - 12
timeFrame: 2 year follow up
measure: Oswestry Disability Index
timeFrame: 2 year follow up
measure: Return to Work
timeFrame: 2 year follow up
measure: Numerical Pain Rating Scale
timeFrame: 2 year follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Research Manager for Spine Research
name: Catherine Himo Gang
role: STUDY_DIRECTOR
affiliation: Associate Professor of Orthopedic Surgery
name: Harvinder Sandhu, MD
role: PRINCIPAL_INVESTIGATOR
References: