Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

Texas Tech University Health Sciences Center

Status and phase: Terminated; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Placebo comparator; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02061774

L14-015

Details and patient eligibility

About

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Full description

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies.

Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status.

To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
• ASA I, II, or III
• Informed consent form signed

Exclusion criteria

• Anyone weighing less than 50kg (as this would require a dosing change).
• Hypersensitivity or contraindication to intravenous acetaminophen or opioids
• Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
• Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
• Mental retardation recorded as a diagnosis in the patient's chart
• History of chronic pain (defined as currently receiving treatment from a specialist for pain)
• History of pain recalcitrant to intravenous morphine
• Impaired kidney function (defined as creatinine > 1.5)
• Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

acetaminophen

Active Comparator group

Description:

1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours

Treatment:

Drug: Acetaminophen

PlaceboComparator

Placebo Comparator group

Description:

Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours

Treatment:

Drug: Placebo comparator