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
  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
Endpoint Classification: Safety/Efficacy Study
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 Outcomes Research Consortium:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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: Group A
General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion
Drug: placebo
General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion
Active Comparator: Group B
B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia
Drug: Lidocaine
General Anesthesia plus perioperative intravenous lidocaine infusion and post operative patient controlled analgesia
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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
Outcomes Research Consortium
Investigators
Principal Investigator: Ehab Farag, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Ehab Farag, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00840996     History of Changes
Obsolete Identifiers: NCT00706524
Other Study ID Numbers: 08-209
Study First Received: February 10, 2009
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Spine Surgery
Intraocular pressure
Lidocaine
Epidural Anesthetic

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

ClinicalTrials.gov processed this record on September 14, 2014