Clinical trial NCT03669744: Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Official title: Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: chronic pain
trigeminal neuralgia
regional anesthesia
trigeminal nerve block
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria treating by one or more trigeminal nerve blocks at the peri operative pain management center of Limoges University Hospital between 2014 and 2018.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Major patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria
* treating by one or more trigeminal nerve blocks
* at the peri operative pain management center of Limoges University Hospital
* between 2014 and 2018

Exclusion Criteria:

* Not consent
* Another type of facial block during the previous year.
* Unavailable medical data
* Deceased patient

Primary outcomes:
measure: Change of the quality of life from baseline to day 15 after baseline
timeFrame: Day 0, Day 15
Secondary outcomes:
measure: Change in pain level just before and after the block assessed by a numerical scoring scale
timeFrame: Day 0, Day 15
measure: Neuropathic criteria of pain just before and after the block assessed by DN4
timeFrame: Day 0
measure: Duration of the block
timeFrame: Day 0
measure: Patient overall satisfaction assessed by a Numerical Rating Scale.
timeFrame: Day 0
measure: Impact on analgesics consumption assessed by the dosage of analgesics
timeFrame: Day 0
measure: Side effects
timeFrame: Day 0
measure: Return to work
timeFrame: Day 0
measure: Return to hobbies
timeFrame: Day 0
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Nathalie NATHAN-DENIZOT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: