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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
Lidocaine	Lidocaine	Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.

Primary Outcome Measures

Name	Time	Method
Mean Pain Scores	From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).	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).
Opioid Medication Requirement, mg in IV Morphine Equivalent	through postoperative day 2 (or discharge, if earlier)	Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents

Secondary Outcome Measures

Name	Time	Method
Postoperative Nausea and Vomiting (PONV)	post op day one and two or till hospital discharge	Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.
Number of Participants With Any Major 30-day Post Operative Complications	30 days after surgery	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.
Duration of Hospitalization	At discharge	Length of hospital stay will be recorded in days.
12-item Short Form Survey (SF-12) Physical Health Composite Score	90 days post operative	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.