UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043921 |
|---|---|
| Receipt number | R000049557 |
| Scientific Title | Efficacy of ultrasound guided Maxillary/Mandibular nerve block for trigeminal neuralgia using two techniques |
| Date of disclosure of the study information | 2021/04/25 |
| Last modified on | 2021/04/17 08:39:04 |
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Basic information
Public title
Efficacy of ultrasound guided Maxillary/Mandibular nerve block for trigeminal neuralgia using two techniques
Acronym
Efficacy of ultrasound guided Maxillary/Mandibular nerve block for trigeminal neuralgia using two techniques
Scientific Title
Efficacy of ultrasound guided Maxillary/Mandibular nerve block for trigeminal neuralgia using two techniques
Scientific Title:Acronym
Efficacy of ultrasound guided Maxillary/Mandibular nerve block for trigeminal neuralgia using two techniques
Region
| Japan |
Condition
Condition
Trigeminal neuralgia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many patients suffer from trigeminal neuralgia. When surgery is not indicated and pharmacological treatment or superficial peripheral nerve block prove insufficient, semi-permanent deeper blocks including gasserian ganglion block with ethanol or radio frequency, were performed in our facility, but there are severe risks involved with this. Recently, there have been reports on ultrasound-guided maxillary and mandibular nerve block for trigeminal neuralgia (in-plane approach: lateral approach). From 2017, these local anesthetic blocks were administered instead of semi-permanent blocks in our facility. In addition, we have suggested the new approach (out-of-plane approach: anterior approach), which could make it easier to perform the block in some patients. The aim of this study is to examine the efficacy and the safety of these blocks compared to the treatments we had provided in the past.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement in the pain management after the treatment with ultrasound guided mandibular and/or maxillary nerve block
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who come to our pain clinic with severe trigeminal neuralgia and those who are not eligible for the surgery and had not been treated enough with the other treatments such as superficial blocks and medications.
Key exclusion criteria
Patients who are contraindicated to block therapy or the use of local anesthetics are excluded. Those who do not wish to be treated with this block are also excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Anesthesiology
Zip code
130-8575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
03-3633-6151
hirano-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Anesthesiology
Zip code
130-8575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
03-3633-6151
Homepage URL
hirano-a@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Bokutoh Hospital
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
Tel
0336336151
hirano-a@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We performed, and will perform, ultrasound-guided maxillary or mandibular nerve block (0.75% Ropivacaine) using either in-plane (lateral pterygoid plate approach) or out-of-plane (anterior approach, suggested by our facility) technique, depending on the patient. The blocks were performed once a week until the severity of pain reduced as a standard treatment. We will examine the efficiency and the side effects of the treatment using the information obtained from the records.
Management information
Registered date
| 2021 | Year | 04 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049557
