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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03669744
Acronym
TRINEB ONE
Enrollment
21
Registered
2018-09-13
Start date
2018-10-09
Completion date
2019-07-09
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

chronic pain, trigeminal neuralgia, regional anesthesia, trigeminal nerve block

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.

Interventions

a telephone survey will be conducted at 21 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.

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Days to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the quality of life from baseline to day 15 after baselineDay 0, Day 15Percentage of patients with improvement of more than 50% in quality of life, mesured with the 'Medical Outcome Study Short Form 12', from baseline (day 0 = just before the block) to day 15. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

Secondary

MeasureTime frameDescription
Neuropathic criteria of pain just before and after the block assessed by DN4Day 0Average value of the DN4 score before and after the block. DN4 questionnaire helps estimate the likelihood of neuropathic pain. The maximum score is 10. The threshold value for the diagnosis of neuropathic pain is 4.
Duration of the blockDay 0Number of days before covering an VAS justifying a new block
Patient overall satisfaction assessed by a Numerical Rating Scale.Day 0Average value of the Numerical Rating Scale. Zero represents 'not at all satisfied' whereas ten represents 'very satisfied'.
Change in pain level just before and after the block assessed by a numerical scoring scaleDay 0, Day 15Average value of the Numerical Rating Scale immediately before, after and at day 15 after the block. Zero represents 'no pain at all' whereas ten represents 'the worst pain ever possible'
Side effectsDay 0To list side effects
Return to workDay 0For the patients concerned: yes / no
Return to hobbiesDay 0For the patients concerned: yes / no
Impact on analgesics consumption assessed by the dosage of analgesicsDay 0doses of analgesics compared to those usually delivered

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026