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

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Other: telephone survey

• Registration Number: NCT03669744
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2018-10-09
• Status Verified: 2019-07
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with trigeminal neuralgia resistant	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

Primary Outcome Measures

Name	Time	Method
Change of the quality of life from baseline to day 15 after baseline	Day 0, Day 15	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.

Secondary Outcome Measures

Name	Time	Method
Patient overall satisfaction assessed by a Numerical Rating Scale.	Day 0	Average value of the Numerical Rating Scale. Zero represents 'not at all satisfied' whereas ten represents 'very satisfied'.
Impact on analgesics consumption assessed by the dosage of analgesics	Day 0	doses of analgesics compared to those usually delivered
Side effects	Day 0	To list side effects
Change in pain level just before and after the block assessed by a numerical scoring scale	Day 0, Day 15	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'
Duration of the block	Day 0	Number of days before covering an VAS justifying a new block
Return to work	Day 0	For the patients concerned: yes / no
Return to hobbies	Day 0	For the patients concerned: yes / no
Neuropathic criteria of pain just before and after the block assessed by DN4	Day 0	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.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France