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Effect of IV Lidocaine Infusions on Pain

This study has been completed.
Information provided by (Responsible Party):
Sean Mackey, Stanford University Identifier:
First received: July 28, 2008
Last updated: June 21, 2012
Last verified: June 2012
Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. Our study will incorporate psychophysical and behavioral testing both before and during the infusions of lidocaine to determine changes in mood. In addition, we will use functional magnetic resonance imaging to observe what changes occur in the brain during a lidocaine infusion.

Condition Intervention
Drug: Intravenous lidocaine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of IV Lidocaine Infusions on Pain

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Blood Oxygenation Level Dependent (BOLD) signal in insular cortex, prefrontal cortex, rostroventral medulla, ventral tegmental area, and caudate nucleus [ Time Frame: Duration of the 2 hour fMRI scan ]

Enrollment: 22
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Intravenous lidocaine
    Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml
Detailed Description:
Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. Plasma concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of the medical team. This will be conducted according to standard medical practice for the infusion and the study procedures will not affect the infusion paradigm. Total infusion time is approximately 1-2 hours.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:- subjects between the ages of 18 and 100 years for clinical component; subjects between the ages of 18 and 70 for the MRI component

  • meets the study criteria of chronic pain of either peripheral or central origin
  • male or a non-pregnant, non-lactating female. If females are of reproductive potential (i.e., not surgically sterilized and/or not post menopausal), they must be practicing an accepted method of birth control, agree to a urine pregnancy test at the start of each study session (for patient scheduled through the clinic, this has already been addressed by the recommending physician)
  • is not currently on a sodium channel blocking agent, anticonvulsant, or tricyclic antidepressant,
  • must be able to comply with any other study requirements and complete experimental tasks
  • have no reported substance abuse within the past six months;

Exclusion Criteria:- subject is lactating or pregnant;

  • subject suffers from clinically significant cardiac, pulmonary, renal or liver disease;
  • subject allergic to lidocaine.
  • MRI Component: any metal objects (especially surgical clips), devices, or implants or any other MRI contraindication
  Contacts and Locations
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Please refer to this study by its identifier: NCT00725504

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Sean Mackey Stanford University
  More Information

Responsible Party: Sean Mackey, Assistant Professor, Stanford University Identifier: NCT00725504     History of Changes
Other Study ID Numbers: SU-07072008-1232 
Study First Received: July 28, 2008
Last Updated: June 21, 2012

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
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 processed this record on February 28, 2017