| City: |
|
Birmingham |
|
State:
|
|
AL |
| Zip Code: |
|
35294 |
| Conditions: |
|
Back Pain |
| Purpose: |
|
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.
|
| Study summary: |
|
Inadequate pain control after spine surgery in adults can result in increased patient
morbidity and length of hospital stay, whereas improved postoperative pain control has been
demonstrated to have numerous physiologic benefits and to reduce postoperative
complications. When administered systemically, the amide local anesthetic lidocaine has
potent anti-inflammatory properties, including inhibition of the arachidonic acid cascade
and production of eicosanoids and prostaglandins. Previous studies have confirmed that the
continuous intravenous administration of lidocaine during and after abdominal surgery in
adults improves patient rehabilitation (specifically, pain intensity, duration of ileus,
incidence of nausea and vomiting), and shortens hospital stay. The beneficial
anti-inflammatory properties versus untoward side effects of the local anesthetics appear
superior to steroids and the non-steroidal anti-inflammatory drugs (NSAIDs). Moreover,
concern and controversy exists regarding the adverse effects of NSAIDs on bone healing,
particularly in adults undergoing spine surgery.
No study to date has investigated the efficacy of a continuous perioperative lidocaine
infusion in the adult spine surgery population. Therefore, in this prospective, randomized,
controlled trial, we will evaluate the analgesic efficacy, anti-inflammatory properties, and
rehabilitation pattern with a continuous, perioperative intravenous infusion of lidocaine
versus a normal saline placebo in adult patients undergoing a decompressive lumbar
laminectomy for spinal canal stenosis. Subjects enrolled in this study will receive a
standardized general anesthetic that is consistent with our present clinical practice. The
study participants will be randomized to receive both a perioperative bolus (2 mg/kg) and
subsequent intravenous infusion (3 mg/kg/hr) of the amide local anesthetic lidocaine or a
normal saline placebo at an equal volume per hour. The study infusion will be continued for
90 minutes after surgery. All patients will receive ample and adequate intravenous doses of
an opioid (morphine sulfate) to reduce their pain intensity to acceptable levels. Pain
intensity, opioid requirements, opioid-related side effects, and both the immediate and
sustained rehabilitation pattern will be assessed. In addition to plasma lidocaine levels in
the active drug group, plasma C-reactive protein, cortisol, and cytokine levels (e.g., IL-6,
IL-10 and TNF-α) will be obtained at a series of perioperative time points in all study
patients. Postoperative cytokine levels will also be measured in the surgical drainage
fluid. |
| 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 |
|
|
|
| Study is available at: |
|
University of Alabama at Birmingham
Birmingham, AL 35294
United States
Primary Contact:
Theresa Hensley
Email: thensley@uab.edu
Phone: 205-975-2088 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|