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N/A N=178 Randomized Quadruple-blind Treatment

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

Lumbar Osteoarthritis · Spondylosis · Lumbar Disc Disease · Spinal Stenosis

Enrolled (actual)
178
Serious AEs
23.4%
Results posted
Jul 2023
Primary outcome: Primary: Perioperative Opioid Use — 86.25; 306.6; 192.4; 88.95 oral morphine equivalents (OME) (mmg) — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Ketorolac (Drug); Acetaminophen (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Perioperative Opioid Use
86.25; 306.6; 192.4; 88.95; 324; 237.9 <0.001 sig
SECONDARY
Opioid Use at 4-6 Weeks
34; 33; 22; 9; 6; 14 0.048 sig
SECONDARY
Opioid Use at 3 Months
32; 25; 26; 5; 2; 5 0.595
SECONDARY
Opioid Use at 1 Year
32; 31; 21; 1; 0; 1
SECONDARY
Opioid Use at 2 Years
26; 26; 22; 1; 1; 3
SECONDARY
Numerical Pain Rating Scale
4; 3; 12.5; 1; 0; 8.5
SECONDARY
Brief Pain Inventory
6.5; 9; 9; 2; 4; 1.5 0.016 sig
SECONDARY
Opioid Related Side Effects
16; 17; 17; 28; 23; 21
SECONDARY
Perioperative Complications - Drain Output
270; 235; 240; 390; 305; 320 0.928
SECONDARY
Perioperative Complications - Transfusion Rate
40; 42; 41; 4; 1; 0 0.078
SECONDARY
Days to Walk 50 ft With PT
30; 26; 24; 11; 12; 14 0792
SECONDARY
Length of Stay
49.5; 77; 70 0.034 sig
SECONDARY
Veterans Rand - 12
46.6; 51.2; 51.1; 46.4; 44.5; 46.7
SECONDARY
Oswestry Disability Index
14.7; 11.4; 16.0
SECONDARY
Veterans Rand - 12
46.6; 51.2; 51.1; 46.4; 44.5; 46.7
SECONDARY
Oswestry Disability Index
14.7; 11.4; 16.0
SECONDARY
Return to Work
5; 8; 7; 5; 5; 3
SECONDARY
Veterans Rand - 12
46.6; 51.2; 51.1; 46.4; 44.5; 46.7
SECONDARY
Oswestry Disability Index
14.7; 11.4; 16.0
SECONDARY
Return to Work
5; 8; 7; 5; 5; 3
SECONDARY
Numerical Pain Rating Scale
4; 3; 12.5; 1; 0; 8.5
SECONDARY
Veterans Rand - 12
46.6; 51.2; 51.1; 46.4; 44.5; 46.7
SECONDARY
Oswestry Disability Index
14.7; 11.4; 16.0
SECONDARY
Return to Work
5; 8; 7; 5; 5; 3
SECONDARY
Numerical Pain Rating Scale
4; 3; 12.5; 1; 0; 8.5

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.].

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02700451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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