An observational study in Trigeminal Neuralgia, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Days and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by University Hospital, Limoges · Observational
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.
135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's enrollment of 21 is below the median of 82 across 34 observational studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Other: telephone survey
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.
Change of the quality of life from baseline to day 15 after baseline
Percentage 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.
Time frame: Day 0, Day 15
Change in pain level just before and after the block assessed by a numerical scoring scale
Average 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'
Time frame: Day 0, Day 15
Neuropathic criteria of pain just before and after the block assessed by DN4
Average 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.
Time frame: Day 0
Duration of the block
Number of days before covering an VAS justifying a new block
Time frame: Day 0
Patient overall satisfaction assessed by a Numerical Rating Scale.
Average value of the Numerical Rating Scale. Zero represents 'not at all satisfied' whereas ten represents 'very satisfied'.
Time frame: Day 0
Impact on analgesics consumption assessed by the dosage of analgesics
doses of analgesics compared to those usually delivered
Time frame: Day 0
Side effects
To list side effects
Time frame: Day 0
Return to work
For the patients concerned: yes / no
Time frame: Day 0
Return to hobbies
For the patients concerned: yes / no
Time frame: Day 0
Plan to share: No
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Limoges