UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058739 |
|---|---|
| Receipt number | R000067164 |
| Scientific Title | Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery. |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 14:37:38 |
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Basic information
Public title
Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery.
Acronym
Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery.
Scientific Title
Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery.
Scientific Title:Acronym
Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery.
Region
| Japan |
Condition
Condition
Cosmetic blepharoplasty candidates.
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of local anesthetic injection volume on postoperative swelling, bruising, double-eyelid crease stability, and patient satisfaction in buried suture double-eyelid surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative swelling score: postoperative day 1 and day 7 (POD1, POD7)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants will be categorized into three groups, with the anesthetic dose set at low levels.
Interventions/Control_2
Participants will be categorized into three groups, with the anesthetic dose set at medium levels.
Interventions/Control_3
Participants will be categorized into three groups, with the anesthetic dose set at high levels.
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who wish to undergo buried suture double-eyelid Surgery.
who have provided written informed consent for this treatment.
Key exclusion criteria
Patients who have undergone previous blepharoplasty or other eyelid procedures,
who have a predisposition to keloid formation,
who are undergoing treatment with anticoagulant agents,
who have exhibited allergic reactions to anesthetic compounds, or
who are undergoing concurrent surgical intervention involving the periorbital region.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@cybervision21.com
Public contact
Name of contact person
| 1st name | Matsumoto |
| Middle name | |
| Last name | Ryoichi |
Organization
Tokyo Chuo Beauty Clinic (TCB), Skin Clinic, Okayama Branch.
Division name
Director
Zip code
700-0023
Address
4F NARITSU-HARRY Building, 1-1-21 Ekimae-cho, Kita-ku, Okayama-shi, Okayama 700-0023, Japan
TEL
086-238-8632
Homepage URL
dr.matsumoto.ryoichi@cybervision21.com
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Institute
Department
Personal name
Hiroo Teranishi
Funding Source
Organization
None
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
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@medical-frontier.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
| 2025 | Year | 08 | Month | 08 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067164
