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

Completed · Not applicable · Has a placebo group

Conditions studied: Spine Surgery

In brief

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.

Key facts

Study ID

NCT00840996

Run by

The Cleveland Clinic

People needed

116

Starts

2008-05-01

Expected to finish

2012-02-01

Last updated by the study team

2016-12-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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