UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063066 |
|---|---|
| Receipt number | R000072193 |
| Scientific Title | Pain-Reducing Effect of Adding Sodium Bicarbonate (Meylon) to Local Anesthetic on Injection Pain in Thread Lift Surgery: A Single-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/12 |
| Last modified on | 2026/09/27 14:52:37 |
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Basic information
Public title
A Study on Reducing Injection Pain During Local Anesthesia for Thread Lift
Acronym
RIPL-Thread Trial; Reducing Injection Pain in Local anesthesia for Thread lift
Scientific Title
Pain-Reducing Effect of Adding Sodium Bicarbonate (Meylon) to Local Anesthetic on Injection Pain in Thread Lift Surgery: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym
RIPL-Thread Trial; Reducing Injection Pain in Local anesthesia for Thread lift
Region
| Japan |
Condition
Condition
Injection pain during local anesthesia in patients undergoing thread lift surgery
Classification by specialty
| Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference in the Numerical Rating Scale (NRS) scores between the bilateral sides (the side with Meylon addition versus the side without addition). Injection pain during local anesthesia for the thread lift will be evaluated immediately after the procedure for both the left and right sides of the same patient using the NRS, which ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain).
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
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).
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 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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yamauchi |
Organization
Tokyo Chuo Beauty Clinic (TCB), 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 | Daisuke |
| Middle name | |
| Last name | Kitawaki |
Organization
Tokyo Chuo Beauty Clinic (TCB), Kusatsu Branch
Division name
Director
Zip code
5250032
Address
3F, Lty932 Building, 1-1-1 Oji, Kusatsu City, Shiga 525-0032, Japan
TEL
0775981406
Homepage URL
dkfrompeace@gmail.com
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), Kusatsu 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 | 10 | Month | 12 | 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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 27 | Day |
Last modified on
| 2026 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072193
