NCT01955967

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

September 1, 2013

Enrollment Period

5.4 years

First QC Date

September 30, 2013

Last Update Submit

October 7, 2013

Conditions

Trigeminal Neuralgia

Keywords

EffectLidocaine

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    24h

Study Arms (1)

Lidocaine

OTHER
Drug: Lidocaine

Interventions

LidocaineDRUG
Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Stavropoulou E, Argyra E, Zis P, Vadalouca A, Siafaka I. The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial. ISRN Pain. 2014 Mar 10;2014:853826. doi: 10.1155/2014/853826. eCollection 2014.

    PMID: 27335883DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

April 1, 2006

Primary Completion

September 1, 2011

Last Updated

October 8, 2013

Record last verified: 2013-09