Trial record 12 of 29 for:
The Effect of Intravenous Lidocaine on Trigeminal Neuralgia
This study has been completed.
Information provided by (Responsible Party):
Pain Relief & Palliative Care Center, Athens, Greece
First received: September 30, 2013
Last updated: October 7, 2013
Last verified: September 2013
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.
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Primary Outcome Measures:
- Pain intensity [ Time Frame: 24h ] [ Designated as safety issue: No ]
| Study Start Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
(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.
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No Contacts or Locations Provided
No publications provided
||Pain Relief & Palliative Care Center, Athens, Greece
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 30, 2013
||October 7, 2013
||Greece: Ethics Committee
Keywords provided by Pain Relief & Palliative Care Center, Athens, Greece:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Trigeminal Nerve Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Cranial Nerve Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents