UMIN-CTR Clinical Trial

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