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
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
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
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
