N/A
N=178
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Lumbar Osteoarthritis · Spondylosis · Lumbar Disc Disease · Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02700451 ↗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
| Outcome | Result | p-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.
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.