The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

Pain Relief & Palliative Care Center, Athens, Greece0 sites20 target enrollmentApril 2006

ConditionsTrigeminal Neuralgia

InterventionsLidocaine

Overview

Phase: Not Applicable
Intervention: Lidocaine
Conditions: Trigeminal Neuralgia
Sponsor: Pain Relief & Palliative Care Center, Athens, Greece
Enrollment: 20
Primary Endpoint: Pain intensity
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

September 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pain Relief & Palliative Care Center, Athens, Greece

Responsible Party

Sponsor

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.