The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pain Relief & Palliative Care Center, Athens, Greece
ClinicalTrials.gov Identifier:
NCT01955967
First received: September 30, 2013
Last updated: October 7, 2013
Last verified: September 2013
  Purpose

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 Intervention
Trigeminal Neuralgia
Drug: Lidocaine

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

Resource links provided by NLM:


Further study details as provided by Pain Relief & Palliative Care Center, Athens, Greece:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2006
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lidocaine Drug: Lidocaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Pain Relief & Palliative Care Center, Athens, Greece
ClinicalTrials.gov Identifier: NCT01955967     History of Changes
Other Study ID Numbers: 001
Study First Received: September 30, 2013
Last Updated: October 7, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by Pain Relief & Palliative Care Center, Athens, Greece:
Effect
Lidocaine

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Cranial Nerve Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014