UMIN-CTR Clinical Trial

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
Institute	Kyushu Dental University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048882