Overview

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.