IV vs Oral Acetaminophen in Spine Fusion Perioperative Care
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 9/15/2018 |
| Start Date: | January 2017 |
| End Date: | October 2020 |
Single-Center, Randomized Controlled Trial of Intravenous v Oral Acetaminophen Administration in Perioperative Care of 1 and 2 Level XLIFs Supplemented With Bilateral Pedicle Screw Stabilization: a Comparative Effectiveness Study
The United States is currently experiencing an explosive opioid epidemic. In 2014 alone,
28,647 Americans died from an opioid associated overdose; the annual death toll has increased
by over 300% since 2000. The epidemic poses a complex scenario for physicians administering
treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to
severe pain. In order to reduce the patients risk for long term opioid use and the associated
side effects, physicians have begun shifting to multimodal analgesic approaches to treat
postoperative pain. These approaches have been found to be similarly efficacious, while also
reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus.
This study proposes a multimodal analgesic approach, which the investigators believe will
reduce short and long term opioid usage, the associated side effects, and the financial
burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive
pain management, however its use is limited by a high cost to perceived benefit ratio. Oral
acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV
option, and also often not feasible to utilize in the immediate post-operative period when
patients are unable to safely swallow pills. The hypothesis of this investigation is to
understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar
spinal surgery will result in improved pain management in the perioperative period while
decreasing opioid usage and related complications.
28,647 Americans died from an opioid associated overdose; the annual death toll has increased
by over 300% since 2000. The epidemic poses a complex scenario for physicians administering
treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to
severe pain. In order to reduce the patients risk for long term opioid use and the associated
side effects, physicians have begun shifting to multimodal analgesic approaches to treat
postoperative pain. These approaches have been found to be similarly efficacious, while also
reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus.
This study proposes a multimodal analgesic approach, which the investigators believe will
reduce short and long term opioid usage, the associated side effects, and the financial
burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive
pain management, however its use is limited by a high cost to perceived benefit ratio. Oral
acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV
option, and also often not feasible to utilize in the immediate post-operative period when
patients are unable to safely swallow pills. The hypothesis of this investigation is to
understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar
spinal surgery will result in improved pain management in the perioperative period while
decreasing opioid usage and related complications.
Inclusion Criteria:
- Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis
- Skeletally mature adults between the ages of 18-85 years at the time of surgery
- The greater of the patients right and left VAS leg pain, or back pain, score is > 40
mm on a 100 mm scale
- Has attempted conservative therapy
- Psychosocially, mentally, and physically able to fully comply with this protocol,
including adhering to scheduled visits, treatment plan, completing forms, and other
study procedures
- Personally signed and dated informed consent document prior to any study-related
procedures indicating that the patient has been informed of all pertinent aspects of
the study
Exclusion Criteria:
- Any evidence of a prior/current fracture, compromised vertebra, current or past
trauma, or tumor at affected level or the spinous processes at the adjacent levels
- Revision of prior fusion attempt at the level being operated on
- Cauda Equina Syndrome defined as neural compression causing neurogenic bowel (rectal
incontinence) or bladder dysfunction (bladder retention or incontinence)
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy,
caused by conditions other than spinal stenosis
- Significant peripheral vascular disease (diminished dornails pedis or tibial pulses)
- Morbid obesity, defined as BMI > 40 kg/m2; or underweight, defined as BMI < 18.5 kg/m2
- Active systematic or local infection
- Active Viral Hepatitis (receiving medical treatment within 1 year); or any other acute
hepatitis within the past 6 months
- Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome
(AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
- Insulin dependent diabetes mellitus or any other medical conditions that would
represent a significant increase in surgical risk or interfere with normal healing
- Immunologically suppressed, or has received systemic steroids, excluding nasal
steroids, at any dose for >1 month within last 12 months
- History of Paget's disease, osteomalacia, or osteoporosis with a DEXA t-score less
than or equal to -2.5
- Active malignancy. A patient with a history of any invasive malignancy (except
non-melanoma skin cancer), unless treated with curative intent and there has been no
clinical signs or symptoms of the malignancy >5 years
- Any current history of substance abuse (e.g., recreational drugs, narcotics, or
alcohol)
- History of psychosocial disorders that could prevent accurate completion of
self-reporting assessment scales
- Previous known allergy to acetaminophen
- Women who are pregnant or lactating
- Patients involved in active litigation relating to his/her spinal condition
- Patients taking >30mg/day of oral morphine sulfate, or the equivalent of this daily
for more than 3 months
- Patient is unable to ingest orally administered medication
- Patient receiving autologous Iliac Crest bone graft (ICBG)
- Known intolerance of or true allergy to hydromorphone or oxycodone.
- History of moderate to severe Cirrhosis, defined as Child Pugh score of class B, C, or
D
- History of Hemochromatosis or Porphyria
- Patient taking Isoniazid or barbiturates
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