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Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital (TRINEB ONE)

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ClinicalTrials.gov Identifier: NCT03669744
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Trigeminal Neuralgia Other: telephone survey

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Study Type : Observational
Estimated Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : July 9, 2019
Estimated Study Completion Date : July 9, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 :
  1. Change of the quality of life from baseline to day 15 after baseline [ Time Frame: 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 :
  1. Change in pain level just before and after the block assessed by a numerical scoring scale [ Time Frame: 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'

  2. Neuropathic criteria of pain just before and after the block assessed by DN4 [ Time Frame: 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.

  3. Duration of the block [ Time Frame: Day 0 ]
    Number of days before covering an VAS justifying a new block

  4. Patient overall satisfaction assessed by a Numerical Rating Scale. [ Time Frame: Day 0 ]
    Average value of the Numerical Rating Scale. Zero represents 'not at all satisfied' whereas ten represents 'very satisfied'.

  5. Impact on analgesics consumption assessed by the dosage of analgesics [ Time Frame: Day 0 ]
    doses of analgesics compared to those usually delivered

  6. Side effects [ Time Frame: Day 0 ]
    To list side effects

  7. Return to work [ Time Frame: Day 0 ]
    For the patients concerned: yes / no

  8. Return to hobbies [ Time Frame: Day 0 ]
    For the patients concerned: yes / no



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669744


Contacts
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Contact: Nicolas JACQUES, medical intern + 33 6 83 37 31 91 cotatiwork@gmail.com

Locations
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France
University Hospital Recruiting
Limoges, France, 87042
Contact: Nathalie NATHAN DENIZOT, PU-PH         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Nathalie NATHAN-DENIZOT, PU-PH University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03669744     History of Changes
Other Study ID Numbers: 87RI18_0004 (TRINEB ONE)
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
chronic pain
trigeminal neuralgia
regional anesthesia
trigeminal nerve block
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs