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The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Pain Relief & Palliative Care Center, Athens, Greece
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Trigeminal Neuralgia focused on measuring Effect, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) confirmed diagnosis of TN according to IASP definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (VAS) score equal to or greater than 3 (out of a maximum 10), (4) DN4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for TN (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) TN duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Lidocaine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain intensity

    Secondary Outcome Measures

    Full Information

    First Posted
    September 30, 2013
    Last Updated
    October 7, 2013
    Sponsor
    Pain Relief & Palliative Care Center, Athens, Greece
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01955967
    Brief Title
    The Effect of Intravenous Lidocaine on Trigeminal Neuralgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pain Relief & Palliative Care Center, Athens, Greece

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this randomized double blind, placebo controlled, crossover study is to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be measured with pain diaries and visual analogue scales.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigeminal Neuralgia
    Keywords
    Effect, Lidocaine

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Time Frame
    24h

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) confirmed diagnosis of TN according to IASP definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (VAS) score equal to or greater than 3 (out of a maximum 10), (4) DN4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for TN (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) TN duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27335883
    Citation
    Stavropoulou E, Argyra E, Zis P, Vadalouca A, Siafaka I. The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial. ISRN Pain. 2014 Mar 10;2014:853826. doi: 10.1155/2014/853826. eCollection 2014.
    Results Reference
    derived

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    The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

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