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

NCT02700451 NA COMPLETED Results posted

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 \[quicker ambulation with physical therapy (PT), earlier return to work, etc.\].

Details

Lead sponsor	Hospital for Special Surgery, New York
Phase	NA
Status	COMPLETED
Enrolment	178
Start date	2016-03
Completion	2023-03

Conditions

• Lumbar Osteoarthritis
• Spondylosis
• Lumbar Disc Disease
• Spinal Stenosis

Interventions

• Ketorolac
• Acetaminophen
• Placebo

Primary outcomes

• Perioperative Opioid Use — Hospital stay (2-4 days)
  Measure the impact of treatment on total opioid use during the hospital stay

Countries

United States