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

NCT03669744 | Completed

• 1 other identifier: 87RI18_0004 (TRINEB ONE)
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Patients with trigeminal neuralgia resistant

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

Interventions

telephone survey OTHER

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.

Patients with trigeminal neuralgia resistant

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Not consent
• Another type of facial block during the previous year.
• Unavailable medical data
• Deceased patient

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital

Limoges, 87042, France

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie NATHAN-DENIZOT, PU-PH

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: October 9, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)