Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery

Study Overview
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Brief Summary
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Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.

Detailed Description
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Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.

Official Title
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The Effect of Perioperative Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery: A Randomized, Double - Blinded, Placebo Controlled Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Other: Placebo (normal saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18-80 yrs; American Society of Anesthesiology Physical Status I, II or III; and Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery- Exclusion Criteria: Allergy to any of the study medications or anesthetic agents used in the study; American Society of Anesthesiology physical status IV; Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon; History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min History of previous spinal fusion or instrumentation; Diagnosis of cancer of the spine; History of surgery for abscess or osteomyelitis; History of cardiac dysrhythmia or heart block; History of chronic heroin or methadone use; Preoperative use of any systemic corticosteroid; History of seizure disorder; and Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr | Drug: Lidocaine<br>* Lidocaine iv bolus followed by infusion<br>|
| Placebo Comparator: Placebo<br>Normal saline placebo infusion | Other: Placebo (normal saline)<br>* Normal saline bolus followed by infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery |  | At 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain |  | for the first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of recovery, spine surgery, intravenous lidocaine