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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 : Completed
First Posted : September 13, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Tracking Information
First Submitted Date September 5, 2018
First Posted Date September 13, 2018
Last Update Posted Date September 25, 2019
Actual Study Start Date October 9, 2018
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 12, 2018)
  • 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'
  • 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.
  • Duration of the block [ Time Frame: Day 0 ]
    Number of days before covering an VAS justifying a new block
  • 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'.
  • Impact on analgesics consumption assessed by the dosage of analgesics [ Time Frame: Day 0 ]
    doses of analgesics compared to those usually delivered
  • Side effects [ Time Frame: Day 0 ]
    To list side effects
  • Return to work [ Time Frame: Day 0 ]
    For the patients concerned: yes / no
  • Return to hobbies [ Time Frame: Day 0 ]
    For the patients concerned: yes / no
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Official Title Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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-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.
Study Groups/Cohorts 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
Intervention: Other: telephone survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 12, 2018)
21
Original Estimated Enrollment Same as current
Actual Study Completion Date July 9, 2019
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03669744
Other Study ID Numbers 87RI18_0004 (TRINEB ONE)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Limoges
Study Sponsor University Hospital, Limoges
Collaborators Not Provided
Investigators
Principal Investigator: Nathalie NATHAN-DENIZOT, PU-PH University Hospital, Limoges
PRS Account University Hospital, Limoges
Verification Date July 2019