UMIN-CTR Clinical Trial

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

Trigeminal neuralgia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The improvement in the pain management after the treatment with ultrasound guided mandibular and/or maxillary nerve block

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Metropolitan Bokutoh Hospital

Institute

Department

Personal name

Organization

Tokyo Metropolitan Bokutoh Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Metropolitan Bokutoh Hospital

Address

4-23-15 Kotobashi, Sumida-ku, Tokyo

Tel

0336336151

Email

hirano-a@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

04

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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