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

This study has suspended participant recruitment.
(Did not have the research staff necessary to follow through with this study. Research nurse has been hired as of 8/17.)
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01043211
First received: December 28, 2009
Last updated: August 16, 2011
Last verified: August 2011
  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.


Condition Intervention
Back Pain
Drug: Lidocaine Hydrochoride Injection, without epinephrine
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Postanesthesia care unit(PACU)admission duration (in minutes) [ Time Frame: Assessed after discharge from PACU ] [ Designated as safety issue: No ]
  • Post extubation requirement for intravenous fentanyl in operating room (Y/N and mcg/kg) [ Time Frame: Post extubation ] [ Designated as safety issue: No ]
  • Time to first nurse administered morphine dose after PACU admission (in minutes) [ Time Frame: Assessed after PACU admission ] [ Designated as safety issue: No ]
  • Total dose of fentanyl administered intraoperatively (mcg/kg) and in the PACU (mcg/kg) [ Time Frame: Measured post op ] [ Designated as safety issue: No ]
  • Total amount of mophine administered/PCA pump demands and doses and ratio of PCA demands/doses [ Time Frame: 48-72 hours postoperative period ] [ Designated as safety issue: No ]
  • Self reported VAS pain scores (on a 0-100 scale) [ Time Frame: Obtained on admissions to and upon discharge from PCAU, every 4 hours thereafter for the first 48 to 72 hours postoperatively, and at time of initial postoperative mobilization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effect analysis [ Time Frame: Measurements of side effect analysis will be done postoperatively ] [ Designated as safety issue: No ]
  • Pain Intensity Questionnaires [ Time Frame: BPI-SF completed at time of initial and subsequent postop visits, Roland Morris Back Pain Questionnaire completed postop and 12-14 days, 3 mos, 6 mos, 12 mos, and 24 mos postop as compared to baseline value ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
  • Post rehab analysis [ Time Frame: Time to first liquid oral intake, time to initial mobilization, time to discontinuation of study solution infusion, time to discharge order, and to time to actual discharge home ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lidocaine Hydrochoride Injection, without epinephrine
    A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. Immediately thereafter, lidocaine (1%, 10 mg/ml) will be administered on a standardized 0.3 ml/hr/kg (3 mg/kg/hr, maximum 200 mg/hr = 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the lidocaine infusion will be decreased by 50% to 0.15 ml/hr/kg (1.5 mg/kg/hr, maximum 100 mg/hr = 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
    Other Name: Xylocaine
    Drug: Normal Saline
    A standardized 0.2 ml/kg intravenous bolus dose of preservative-free normal saline will be given after anesthetic induction but prior to skin incision. Immediately thereafter, normal saline will be administered on an equal 0.3 ml/hr/kg (maximum 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the normal saline infusion will be decreased by 50% to 0.15 ml/hr/kg (maximum 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
    Drug: Normal Saline
    A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043211

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Thomas R Vetter, M.D., M.P.H University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Thomas R. Vetter, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01043211     History of Changes
Other Study ID Numbers: F091105002
Study First Received: December 28, 2009
Last Updated: August 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Back Pain
Lidocaine

Additional relevant MeSH terms:
Back Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Epinephrine
Epinephryl borate
Lidocaine
Analgesics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014