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TRINEB ONE
Sponsor study identifier
observational
21
1 country
1
Study Start
October 9, 2018
Actual (reported)Primary Completion
July 9, 2019
Actual (reported)Study Completion
July 9, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 9, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2018
Actual (reported)September 13, 2018
Actual (reported)October 9, 2018
Actual (reported)July 9, 2019
Actual (reported)July 9, 2019
Actual (reported)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.
Day 0, Day 15
Change in pain level just before and after the block assessed by a numerical scoring scale
Day 0, Day 15
Neuropathic criteria of pain just before and after the block assessed by DN4
Day 0
Duration of the block
Day 0
Patient overall satisfaction assessed by a Numerical Rating Scale.
Day 0
Impact on analgesics consumption assessed by the dosage of analgesics
Day 0
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University Hospital
Limoges, 87042, France
Nathalie NATHAN-DENIZOT, PU-PH
University Hospital, Limoges
21 participants (actual enrollment reported by the registry).
First Submitted
September 5, 2018
First Posted
September 13, 2018
Study Start
October 9, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 9, 2019
Actual (reported)Study Completion
July 9, 2019
Actual (reported)Last Updated
September 25, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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