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NCT03669744: TRINEB ONE

Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital

Completed Last updated 25 September 2019
What this trial tests

trial testing telephone survey in Trigeminal Neuralgia in 21 participants. Completed in 9 July 2019.

Timeline
9 October 2018
Primary endpoint
9 July 2019
9 July 2019

Quick facts

Lead sponsorUniversity Hospital, Limoges
StatusCompleted
Study typeOBSERVATIONAL
Enrollment21
Start date9 October 2018
Primary completion9 July 2019
Estimated completion9 July 2019
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Limoges

Who can join

18 Days and older, any sex, with Trigeminal Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trigeminal neuralgia is defined according to the third edition of the International Classification of Headache Disorders (ICHD-3) criteria. Chronic pain can have a major impact on the quality of life. First-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. Sometimes the pain is resistant to these therapies. In this indication, sensory blocks may have a therapeutic impact but their place is not clear. In France, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. Several adjuvants to local anesthetics have been studied for acute and chronic pain. CLONIDINE and DEXAMETHASONE are of greatest interest in increasing block duration and reducing opioid consumption. The investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. After a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. The sensory block is performed as an outpatient care. It consists in a peri-neural injection of a mixture of LEVOBUPIVACAINE 5%, CORTIVAZOL 3.75mg / 1.5mL (or BETAMETHASONE 7mg / 1ml) and CLONIDINE (1μg / kg). Standard precautions are respected and patients are monitored in the recovery room after the procedure. The efficacity is evaluated before the exit and a follow-up is done within 15 days. The level of satisfaction expressed by the patients seems to be globally high. The investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. This retrospective study, by its procedure, does not change the management of patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Quality of life after trigeminal nerve block in refractory trigeminal neuralgia: A retrospective cohort study and literature review.
    Jacques N, Karoutsos S, Marais L, Nathan-Denizot N. · · 2022 · cited 7× · PMID 36281027 · DOI 10.1177/03000605221132027

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