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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043921
Receipt No. 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

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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
Email 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
Email hirano-a@umin.ac.jp

Sponsor
Institute Tokyo Metropolitan Bokutoh Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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