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Trial record 31 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01955967
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):
Pain Relief & Palliative Care Center, Athens, Greece

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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : April 2006
Actual Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Lidocaine Drug: Lidocaine

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 24h ]

Information from the National Library of Medicine

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

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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pain Relief & Palliative Care Center, Athens, Greece Identifier: NCT01955967     History of Changes
Other Study ID Numbers: 001
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013
Keywords provided by Pain Relief & Palliative Care Center, Athens, Greece:
Additional relevant MeSH terms:
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Neuromuscular Diseases
Trigeminal Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
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