Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery

Withdrawn before enrolling · Not applicable

Conditions studied: Back Pain

In brief

The purpose of this study is to generate further insight into the role and effectiveness of the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine surgery. The effect of perioperative intravenous lidocaine infusion on postoperative rehabilitation and the inflammatory response will also be examined.

Key facts

Study ID

NCT01043211

Run by

University of Alabama at Birmingham

People needed

0

Starts

2012-01-01

Expected to finish

2014-03-01

Last updated by the study team

2015-03-10

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 19 years to 80 years of age
• American Society of Anesthesiologists 1-3 status
• Undergoing lumbar laminectomy between levels L1 and S1 for decompression of degenerative lumbar canal stenosis but without fusion or internal fixation performed

You may not qualify if…

• American Society of Anesthesiologists 4 status
• Previous spinal fusion surgery but patient may have undergone previous lumbar laminectomy or lumbar open discectomy
• Morbid obesity (BMI > 40)
• Diagnosis of spinal metastatic cancer
• Presence of a severe or systemic bacterial infection
• Allergy to an amide local anesthetic or morphine sulfate
• History of a seizure disorder
• History of atrial or ventricular arrhythmia
• History of autonomic dysfunction (e.g., dysautonomia of diabetes)
• History of renal dysfunction, liver dysfunction or congestive heart failure
• History of substance abuse disorder
• History of major psychiatric disorder (e.g., depression, bipolar disorder, Axis II personality disorder, schizophrenia)
• Chronic opioid use of greater than 100 mg/day of morphine equivalents within 30 days prior to surgery
• Current use of a corticosteroid
• Use of a non-steroidal anti-inflammatory drug (NSAID), including low dose aspirin within the past 5 days
• Use of an arrhythmic drug within the past 7 days
• Current administration of a known potent CYP1A2 inhibitor, including zileuton (Zyflo), ciprofloxacin, enoxacin or any other fluoroquinolone antibiotic, amiodarone, mexiletine, propafenone, verapamil, cimetidine (Tagamet), famotidine (Pepcid), oral contraceptives, acyclovir (Zovirax) and ticlopidine (Ticlid) (Horn \& Hansten, 2008).
• Current administration of a known potent CYP3A4 inhibitor, including erythromycin, clarithromycin, azole antifungal (ketoconazole, fluconazole), verapamil, diltiazem, and grapefruit juice (Scuderi et al., 2006).
• Pregnant females

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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