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

Trigeminal Neuralgia Clinical Trial

— TRINEB ONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669744
• Other study ID #: 87RI18_0004 (TRINEB ONE)
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Major patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3ß 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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Other:
• telephone survey
a telephone survey will be conducted at 21 patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3ß criteria treating by one or more trigeminal nerve blocks at the peri operative pain management center of Limoges University Hospital between 2014 and 2018.

Locations

Country	Name	City	State
France	University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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'	Day 0, Day 15
Secondary	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.	Day 0
Secondary	Duration of the block	Number of days before covering an VAS justifying a new block	Day 0
Secondary	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'.	Day 0
Secondary	Impact on analgesics consumption assessed by the dosage of analgesics	doses of analgesics compared to those usually delivered	Day 0
Secondary	Side effects	To list side effects	Day 0
Secondary	Return to work	For the patients concerned: yes / no	Day 0
Secondary	Return to hobbies	For the patients concerned: yes / no	Day 0