Effect of IV Lidocaine Infusions on Pain

January 24, 2019 updated by: Sean Mackey, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sean Mackey, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-07072008-1232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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