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

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00840996
First received: February 10, 2009
Last updated: August 24, 2012
Last verified: August 2012

February 10, 2009
August 24, 2012
May 2008
December 2011   (final data collection date for primary outcome measure)
  • pain scores [ Time Frame: day one ] [ Designated as safety issue: No ]
    The pain score as measured by VAS every 30 minutes during PACU stay, then per nursing floor protocol (roughly every 4-6 hours), and pain medications requirement for entire hospital stay in the two groups.
  • pain medication requirement [ Time Frame: daily, for duration of hospital stay ] [ Designated as safety issue: No ]
    The pain score as measured by VAS every 30 minutes during PACU stay, then per nursing floor protocol (roughly every 4-6 hours), and pain medications requirement for entire hospital stay in the two groups.
To assess whether Lidocaine/IVPCA is better in morphine requirements and simultaneously not worse in pain control measured by VAS pain score compared to IVPCA alone. [ Time Frame: post-operatively, one month and three months post operatively ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840996 on ClinicalTrials.gov Archive Site
  • major post operative complications [ Time Frame: daily, throughout hospitalization ] [ Designated as safety issue: No ]
    The occurrence in an individual of one or more major complications.
  • Inflammatory markers [ Time Frame: day one and two ] [ Designated as safety issue: No ]
    Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after the operation at time (T1), and on postoperative day one and two (T2 and T3).
  • Postoperative Nausea and Vomiting (PONV) [ Time Frame: day one ] [ Designated as safety issue: No ]
    Postoperative Nausea and Vomiting (PONV)will be noted during day one post operative.
  • Postoperative Bowel Function [ Time Frame: daily through hospitalization ] [ Designated as safety issue: No ]
    Patients will be questioned at each visit and asked to note the time of first flatus and first bowel movement. Oral intake will be measured until subjects tolerated regular meals.
  • Duration of hospitalization [ Time Frame: daily ] [ Designated as safety issue: No ]
    Length of hospital stay will be recorded in days.
  • Return to function [ Time Frame: 30 days post operative ] [ Designated as safety issue: No ]
    We will evaluate several aspects of post-surgical recovery and return to normal function. Our major instrument will be the Acute SF 12 health survey.
  • Return to function [ Time Frame: 90 days post operative ] [ Designated as safety issue: No ]
    We will evaluate several aspects of post-surgical recovery and return to normal function. Our major instrument will be the Acute SF 12 health survey.
  • Consumption of Neuromuscular blocker [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Before 45 min to end of surgery rocuronium infusion will be stopped and total consumption of muscle relaxant will be recorded.
Not Provided
Not Provided
Not Provided
 
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spine Surgery
  • Drug: Lidocaine
    General Anesthesia plus perioperative intravenous lidocaine infusion and post operative patient controlled analgesia
    Other Name: Liodocaine
  • Drug: placebo
    General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion
  • Placebo Comparator: Group A
    General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion
    Intervention: Drug: placebo
  • Active Comparator: Group B
    B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia
    Intervention: Drug: Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 80 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
  • Male or female patients undergoing complex spinal surgery.
  • Spine surgery
  • Two levels laminectomies or above with or without fusion or instrumentation
  • Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team

Exclusion Criteria:

  • Allergy or hypersensitivity to sufentanil, bupivacaine, or any component of formulations
  • Current or recent drug abuse (within past 6 months)
  • Pregnancy
  • Immune system disease such as HIV, AIDS
  • Undergoing immunosuppressive treatment
  • Recent history of sepsis
  • Contraindications to lidocaine such as heart block and hepatic insufficiency
  • Heart failure with ejection fraction less than 30%
  • Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00840996
08-209
No
Ehab Farag, MD, Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Ehab Farag, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Outcomes Research Consortium
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP