Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

Study Overview
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Brief Summary
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The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups; - A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion. B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.

Detailed Description
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According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970. IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus. There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients. Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.

Official Title
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Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery

Conditions
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Spine Surgery

Intervention / Treatment
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* Drug: Lidocaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient. Elective spine surgery Two levels laminectomies or above with or without fusion or instrumentatioN General anesthesia Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team Exclusion Criteria: contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal) renal impairment (serum creatinine >2 mg/dl), seizure disorder requiring medication within 2 years planned epidural anesthesia or analgesia

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia. | Drug: placebo<br>* perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours<br>|
| Active Comparator: Lidocaine<br>Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia. | Drug: Lidocaine<br>* perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours<br>* Other names: Liodocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Scores | The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours). | From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier). | 
| Opioid Medication Requirement, mg in IV Morphine Equivalent | Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents | through postoperative day 2 (or discharge, if earlier) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Major 30-day Post Operative Complications | The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission. | 30 days after surgery | 
| Postoperative Nausea and Vomiting (PONV) | Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative. | post op day one and two or till hospital discharge | 
| Duration of Hospitalization | Length of hospital stay will be recorded in days. | At discharge | 
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 30 days post operative | 
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 90 days post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Surgery, Intraocular pressure, Lidocaine, Epidural Anesthetic