Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061633) titled 'A Study on Reducing Injection Pain During Local Anesthesia for Double Eyelid Surgery' on May 19.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - okyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch

Condition: Condition - Injection pain during local anesthesia in patients undergoing buried-suture double eyelid blepharoplasty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate whether the addition of 7% sodium bicarbonate (Meylon) to local anesthetic (1% lidocaine with epinephrine) at a 9:1 ratio reduces injection pain during buried-suture double eyelid blepharoplasty. Using a single-blind, split-face, randomized controlled design within the same patient, the primary endpoint is the difference in Numerical Rating Scale scores between the two sides. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention arm (sodium bicarbonate-added side): Local anesthetic prepared by mixing 1% lidocaine with epinephrine and 7% sodium bicarbonate (Meylon) at a 9:1 ratio is administered to one eyelid as local anesthesia before buried-suture double eyelid blepharoplasty. On the skin side, 0.02 mL is injected at each of 4, and 0.3 mL in total is injected on the conjunctival side. Interventions/Control_2 - Control arm (non-added side): Conventional 1% lidocaine with epinephrine (without sodium bicarbonate) is administered to the contralateral eyelid as local anesthesia before buried-suture double eyelid blepharoplasty. The route of administration, total volume, and number of injection points are identical to those of the intervention arm (0.02 mL at each of 4 on the skin side, and 0.3 mL in total on the conjunctival side).

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Patients who request buried-suture double eyelid blepharoplasty including revision cases. (2) Patients who are 20 years of age or older at the time of consent. (3) Patients who have provided written informed consent to participate in this study. Key exclusion criteria - (1) Minors under 20 years of age. (2) Patients with a history of allergy to lidocaine (Xylocaine) or sodium bicarbonate (Meylon). (3) Patients who are pregnant or possibly pregnant. (4) Patients taking oral corticosteroids at a dose of 10 mg/day or higher. (5) Patients with serious comorbidities (e.g., cardiac, hepatic, or renal disease). (6) Patients with active malignancy. (7) Other patients judged by the principal investigator to be unsuitable for participation in this study. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 19 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070512

Disclaimer: Curated by HT Syndication.