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Completed

NCT Number: NCT00840996

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

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.

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Key information

Conditions

Spine Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Other names: Liodocaine

Placebo

Drug

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

Primary outcomes

  1. Mean Pain Scores

    Time frame: 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).

  2. Opioid Medication Requirement, mg in IV Morphine Equivalent

    Time frame: through postoperative day 2 (or discharge, if earlier)

    Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents

Secondary outcomes

  1. Number of Participants With Any Major 30-day Post Operative Complications

    Time frame: 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.

  2. Postoperative Nausea and Vomiting (PONV)

    Time frame: 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.

  3. Duration of Hospitalization

    Time frame: At discharge

    Length of hospital stay will be recorded in days.

  4. 12-item Short Form Survey (SF-12) Physical Health Composite Score

    Time frame: 30 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.

  5. 12-item Short Form Survey (SF-12) Physical Health Composite Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 11, 2009
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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