UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061633 |
|---|---|
| Receipt number | R000070512 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/05/19 |
| Last modified on | 2026/05/19 15:00:55 |
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Basic information
Public title
A Study on Reducing Injection Pain During Local Anesthesia for Double Eyelid Surgery
Acronym
MELT Study; MEylon for Local anesthesia Trial
Scientific Title
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
Scientific Title:Acronym
MELT Study; MEylon for Local anesthesia Trial
Region
| Japan |
Condition
Condition
Injection pain during local anesthesia in patients undergoing buried-suture double eyelid blepharoplasty
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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).
Interventions/Control_3
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
| 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 sample size
30
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-shi, Osaka 530-0057, Japan
TEL
06-6147-2581
umeda.office@tcb.or.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Nakajo |
Organization
Tokyo Chuo Beauty Clinic (TCB), Kyoto Shijo Branch
Division name
Director
Zip code
6008007
Address
5F Kyoto Shoken Building, 66 Tachiuri-Nishimachi, Higashinotoin-Higashi-iru, Shijo-dori, Shimogyo-ku
TEL
08053426718
Homepage URL
s.nakajo1220@gmail.com
Sponsor or person
Institute
okyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Institute
Department
Personal name
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-shi, Osaka 530-0057, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2026 | Year | 05 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070512
