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Effect of IV Lidocaine Infusions on Pain

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ClinicalTrials.gov Identifier: NCT00725504
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : April 17, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Description
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Brief Summary:
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 pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.

Condition or disease Intervention/treatment Phase
Pain Drug: Intravenous lidocaine Not Applicable

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. During the course of the study, the primary outcome measure was changed from blood oxygenation level dependent (BOLD) signal to pain intensity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of IV Lidocaine Infusions on Pain
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine infusion
Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
 Drug: Intravenous lidocaine
Intravenous lidocaine administered up to 5 µg/ml.


Outcome Measures
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Primary Outcome Measures :
  1. Present Pain Intensity [ Time Frame: Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level ]
    Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725504


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sean Mackey Stanford University
More Information
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Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00725504    
Other Study ID Numbers: SU-07072008-1232
First Posted: July 30, 2008    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: February 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
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