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OpenTrials
Completed

NCT Number: NCT00725504

Effect of IV Lidocaine Infusions on Pain

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Lidocaine

Drug

Intravenous lidocaine administered up to 5 µg/ml.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2008
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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