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NCT01955967 Clinical Trial

The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01955967
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received September 30, 2013
Last updated October 7, 2013
Start date April 2006

Study information
Verified date September 2013
Source Pain Relief & Palliative Care Center, Athens, Greece
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pain Relief & Palliative Care Center, Athens, Greece

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity 24h No
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