Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital (TRINEB ONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03669744|
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|Trigeminal Neuralgia||Other: telephone survey|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital|
|Actual Study Start Date :||October 9, 2018|
|Actual Primary Completion Date :||July 9, 2019|
|Actual Study Completion Date :||July 9, 2019|
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.
- 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.
- 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
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
|Limoges, France, 87042|
|Principal Investigator:||Nathalie NATHAN-DENIZOT, PU-PH||University Hospital, Limoges|