Clinical trial NCT02061774: Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Official title: Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: acetaminophen in transforaminal lumbar interbody fusion
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: Q4 x 24 hours averaged
Secondary outcomes:
measure: Level of 100% Sedation
timeFrame: 4-hr intervals for a 24-hr period averaged
measure: Vital Signs
timeFrame: 4-hour intervals (+/- 30 minutes) for 24-hrs averaged
Other outcomes:
measure: Total PCA Morphine
timeFrame: Duration of operation
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center
state: Texas
Study officials:
affiliation: TTUHSC department of Surgery
name: Jason Felton, MD
role: PRINCIPAL_INVESTIGATOR
References: