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A Study on Reducing Injection Pain During Local Anesthesia for Double Eyelid Surgery

Pain-Reducing Effect of Adding Sodium Bicarbonate (Meylon) to Local Anesthetic on Injection Pain in Buried-Suture Double Eyelid Surgery: A Single-Blind Randomized Controlled Trial - MELT Study; MEylon for Local anesthesia Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061633
Enrollment
30
Registered
2026-05-19
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection pain during local anesthesia in patients undergoing buried-suture double eyelid blepharoplasty

Interventions

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 l

Sponsors

okyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The within patient difference in injection pain during local anesthesia, measured by the Numerical Rating Scale, between the sodium bicarbonate added side and the non added side. Pain is assessed by patient self-report immediately after the procedure for each eyelid separately.

Countries

Japan

Contacts

Public ContactShoichiro Nakajo

Tokyo Chuo Beauty Clinic (TCB), Kyoto Shijo Branch Director

s.nakajo1220@gmail.com08053426718

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026