UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061728 |
|---|---|
| Receipt number | R000070581 |
| Scientific Title | The efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery: a prospective observational study |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/29 11:01:51 |
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Basic information
Public title
The efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery: a prospective observational study
Acronym
The efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery: a prospective observational study
Scientific Title
The efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery: a prospective observational study
Scientific Title:Acronym
The efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery: a prospective observational study
Region
| Japan |
Condition
Condition
deformity of jaw
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of maxillary nerve block for postoperative pain relief after two-jaw orthognathic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain-intensity score(Visual Analogue Scale: VAS) at 3 hours after the end of anesthetic management and at next morning
Key secondary outcomes
Usage of analgesics, Nausea-intensity score(Visual Analogue Scale: VAS) at 3 hours after the end of anesthetic management and at next morning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
The participants in the intervention group receive maxillary nerve block with 0.5% levobupivacaine or 0.75% ropivacaine 5-8ml before surgery.
Interventions/Control_2
The participants in the control group receive no treatments.
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients aged 16 to 50 who are scheduled to undergo two-jaw orthognathic surgery by the oral and maxillofacial surgeon in our institution.
Key exclusion criteria
The patients who refuse to participate, have a psychiatric disorder, and contraindicate maxillary nerve block.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | masayuki |
| Middle name | |
| Last name | okada |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2, Iidanishi, Yamagatashi, Yamagata
TEL
023-628-5400
mokada@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | masayuki |
| Middle name | |
| Last name | okada |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2, Iidanishi, Yamagatashi, Yamagata
TEL
023-628-5400
Homepage URL
mokada@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
okada masayuki
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine Rinsyokenkyukanri center
Address
2-2-2, Iidanishi, Yamagatashi, Yamagata
Tel
023-628-5840
m-suto@med.id.yamagata-u.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
山形大学医学部附属病院(山形県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070581
