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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 (Responsible Party):
Ehab Farag, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00840996
First received: February 10, 2009
Last updated: October 31, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Spine Surgery
Drug: Lidocaine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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).

  • 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 Outcome Measures:
  • 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.

  • 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.

  • Duration of Hospitalization [ Time Frame: At discharge ]
    Length of hospital stay will be recorded in days.

  • 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.

  • 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.


Enrollment: 116
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
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
Active Comparator: Lidocaine
Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.
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
Other Name: Liodocaine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840996

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Ehab Farag, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

Responsible Party: Ehab Farag, Ehag Farag, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00840996     History of Changes
Obsolete Identifiers: NCT00706524
Other Study ID Numbers: 08-209 
Study First Received: February 10, 2009
Results First Received: June 27, 2016
Last Updated: October 31, 2016

Keywords provided by The Cleveland Clinic:
Spine Surgery
Intraocular pressure
Lidocaine
Epidural Anesthetic

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 24, 2017