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

• Status: Active, not recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.].

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Ketorolac; Ketorolac Tromethamine

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.