UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057867 |
|---|---|
| Receipt number | R000066145 |
| Scientific Title | Evaluation of the Impact of Ultrasound-Guided Trigeminal Nerve Block (USG-TNB) on Perioperative Management in Orthognathic Surgery |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/05/14 19:12:25 |
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Basic information
Public title
Evaluation of the Impact of Ultrasound-Guided Trigeminal Nerve Block (USG-TNB) on Perioperative Management in Orthognathic Surgery
Acronym
Study on the Impact of Nerve Block in Orthognathic Surgery
Scientific Title
Evaluation of the Impact of Ultrasound-Guided Trigeminal Nerve Block (USG-TNB) on Perioperative Management in Orthognathic Surgery
Scientific Title:Acronym
USG-TNB Ortho Study
Region
| Japan |
Condition
Condition
Orthognathic deformity
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
his study aims to retrospectively assess the effects of ultrasound-guided trigeminal nerve block (USG-TNB) on perioperative management in patients undergoing bimaxillary surgery, to help establish more effective pain management approaches.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraoperative drug consumption
Key secondary outcomes
Clinical data extracted from anesthesia and surgical records as well as medical records
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older at the time of anesthesia consent, with no or mild systemic disease (ASA-PS 1 or 2).
Key exclusion criteria
(1) Patients who decline to participate in the study
(2) Patients deemed ineligible for participation by the principal investigator or co-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Maeda |
Organization
Institute of Science Tokyo
Division name
Department of Dental Anesthesiology, Graduate School of Medical and Dental Science
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
81-3-5803-5548
maedas.daop@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kawauchi |
Organization
Institute of Science Tokyo
Division name
Department of Dental Anesthesiology, Graduate School of Medical and Dental Science
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
81358035548
Homepage URL
kawauchi.aki@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
Tel
+81-3-5803-5548
kawauchi.aki@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
S2024-022
Org. issuing International ID_1
Institute of Science Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 15 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study that evaluates the impact of ultrasound-guided trigeminal nerve block (USG-TNB) on perioperative management in patients who underwent bimaxillary orthognathic surgery.
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066145
