Overview
Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery
Status:
Withdrawn
Withdrawn
Trial end date:
2014-03-01
2014-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Alabama at BirminghamTreatments:
Analgesics
Epinephrine
Lidocaine
Criteria
Inclusion Criteria:1. 19 years to 80 years of age
2. American Society of Anesthesiologists 1-3 status
3. Undergoing lumbar laminectomy between levels L1 and S1 for decompression of
degenerative lumbar canal stenosis but without fusion or internal fixation performed
Exclusion Criteria:
1. American Society of Anesthesiologists 4 status
2. Previous spinal fusion surgery but patient may have undergone previous lumbar
laminectomy or lumbar open discectomy
3. Morbid obesity (BMI > 40)
4. Diagnosis of spinal metastatic cancer
5. Presence of a severe or systemic bacterial infection
6. Allergy to an amide local anesthetic or morphine sulfate
7. History of a seizure disorder
8. History of atrial or ventricular arrhythmia
9. History of autonomic dysfunction (e.g., dysautonomia of diabetes)
10. History of renal dysfunction, liver dysfunction or congestive heart failure
11. History of substance abuse disorder
12. History of major psychiatric disorder (e.g., depression, bipolar disorder, Axis II
personality disorder, schizophrenia)
13. Chronic opioid use of greater than 100 mg/day of morphine equivalents within 30 days
prior to surgery
14. Current use of a corticosteroid
15. Use of a non-steroidal anti-inflammatory drug (NSAID), including low dose aspirin
within the past 5 days
16. Use of an arrhythmic drug within the past 7 days
17. 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).
18. Current administration of a known potent CYP3A4 inhibitor, including erythromycin,
clarithromycin, azole antifungal (ketoconazole, fluconazole), verapamil, diltiazem,
and grapefruit juice (Scuderi et al., 2006).
19. Pregnant females