Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058739) titled 'Impact of Anesthetic Dosage on Clinical Outcomes and Patient Satisfaction in Buried Suture Double-Eyelid Surgery' on Aug. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -but assessor(s) are blinded
Control - Dose comparison
Primary Sponsor:
Institute - Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Condition:
Condition - Cosmetic blepharoplasty candidates.
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 15
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 Size - 60
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067164
Disclaimer: Curated by HT Syndication.
