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

NCT00840996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2016-12-23

Study results available
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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.

Conditions

  • Spine Surgery

Interventions

DRUG

Lidocaine

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

DRUG

placebo

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Ehab Farag, MD · The Cleveland Clinic

  • Daniel I Sessler, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00840996 on ClinicalTrials.gov