Tokyo, Oct. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063066) titled 'A Study on Reducing Injection Pain During Local Anesthesia for Thread Lift' on Oct. 12.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokyo Chuo Beauty Clinic (TCB), Kusatsu Branch

Condition: Condition - Injection pain during local anesthesia in patients undergoing thread lift surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate whether the addition of 7% sodium bicarbonate injection (Meylon) to local anesthetic (1% lidocaine with epinephrine) at a 9:1 ratio reduces injection pain during a thread lift. A single-blind, randomized controlled trial will be conducted using a split-face design in the same patient to compare the difference in the Numerical Rating Scale (NRS) between the bilateral sides as the primary outcome. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Experimental group (Meylon-added side):A local anesthetic, prepared by mixing 1% lidocaine with epinephrine and 7% sodium bicarbonate injection (Meylon) at a 9:1 ratio, will be administered as local anesthesia for a thread lift to one side of the face. At each insertion point, 0.5 mL will be injected using a 30G needle at a rate of 0.1 mL/second. Along the thread tracts, 2.5 mL per side (5 mL bilaterally) will be administered using a 23G microcannula at a rate of 0.1 mL/second. Interventions/Control_2 - Control group (Non-Meylon side):As conventional practice, 1% lidocaine with epinephrine (without Meylon addition) will be administered as local anesthesia for the thread lift to the contralateral side of the face. The administration method, dosage, and number of insertion points will be completely identical to those of the experimental group (at each insertion point, 0.5 mL will be injected using a 30G needle at a rate of 0.1 mL/second; along the thread tracts, 2.5 mL per side will be administered using a 23G microcannula at a rate of 0.1 mL/second).

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Patients undergoing a bilateral thread lift where the same type and number of threads are used on both sides. (2) Patients for whom the local anesthesia technique can be fully standardized on both sides. (3) Patients who have provided written informed consent prior to participation. 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)Patients using other sedatives (including nitrous oxide inhalation sedation), analgesics, or anxiolytics during the procedure (8)Other patients judged by the principal investigator to be inappropriate for participation in this study Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Date of IRB - 2026 Year 10 Month 02 Day Anticipated trial start date - 2026 Year 10 Month 12 Day Last follow-up date - 2027 Year 02 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072193

Disclaimer: Curated by HT Syndication.