UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042817
Receipt number R000048882
Scientific Title The effect of sympathetic blockade time by stellate ganglion block on the treatment effect of trigeminal neuropathy
Date of disclosure of the study information 2020/12/22
Last modified on 2020/12/22 17:15:40

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Basic information

Public title

The effect of sympathetic blockade time by stellate ganglion block on the treatment effect of trigeminal neuropathy

Acronym

Effect of sympathetic blockade time on trigeminal neuropathy

Scientific Title

The effect of sympathetic blockade time by stellate ganglion block on the treatment effect of trigeminal neuropathy

Scientific Title:Acronym

Effect of sympathetic blockade time on trigeminal neuropathy

Region

Japan


Condition

Condition

Trigeminal Neuropathy

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of sympathetic blockade time on the treatment of trigeminal neuropathy by comparing the therapeutic effects of local anesthetics with different action times.

Basic objectives2

Others

Basic objectives -Others

Investigation of the Relationship between the Duration of Action of Local Anesthetics and Sympathetic Blockade Time

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quantitative sensory testing

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Stellate ganglion block with levobupivacaine

Interventions/Control_2

Stellate ganglion block with mepivacaine

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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients of both sexes, aged 20 years or older, who were undergoing Le Fort I osteotomy of the maxilla or bilateral sagittal split ramus osteotomy (BSSRO) at Kyushu Dental University Hospital, with an American Society of Anesthesiologists physical status I or II, and who had a diagnosis of infraorbital nerve (ION) and inferior alveolar nerve (IAN) sensory disturbances were included.

Key exclusion criteria

The exclusion criteria were an allergy to the drugs used in this study, pre-existing orofacial sensory impairment, a history of facial trauma or surgery, and major psychiatric disorders.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shunji
Middle name
Last name Shiiba

Organization

Kyushu Dental University

Division name

Department of Science of Physical Functions, Division of Dental Anesthesiology

Zip code

803-8580

Address

2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka

TEL

093-582-1131

Email

shiiba@fa.kyu-dent.ac.jp


Public contact

Name of contact person

1st name Shunji
Middle name
Last name Shiiba

Organization

Kyushu Dental University

Division name

Department of Science of Physical Functions, Division of Dental Anesthesiology

Zip code

803-8580

Address

2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka

TEL

093-582-1131

Homepage URL


Email

shiiba@fa.kyu-dent.ac.jp


Sponsor or person

Institute

Kyushu Dental University

Institute

Department

Personal name



Funding Source

Organization

Kyushu Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Committee, Kyushu Dental University

Address

2-6-1, Manazuru, Kitakyushu, Japan

Tel

093-285-3011

Email

gakusei@kyu-dent.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

2020 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

28

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

Main results already published

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2020 Year 03 Month 26 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 22 Day

Last modified on

2020 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048882


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name