UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034647 |
|---|---|
| Receipt number | R000039501 |
| Scientific Title | Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2020/04/27 07:51:33 |
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Basic information
Public title
Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm
Acronym
Pain relief effect by local anesthetic at botulinum injection
Scientific Title
Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm
Scientific Title:Acronym
Pain relief effect by local anesthetic at botulinum injection
Region
| Japan |
Condition
Condition
blepharospasm
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Blepharospasm (BS) is a disease in which eyelids opening becomes difficult, and in severe cases, effecti it is close to functional blindness. Although effectiveness of botulinum toxin type A (BTX - A) therapy is widely spread, injection site pain greatly affects patient satisfaction. Therefore, as the local anesthetics are also applied to insurance for adults, we evaluate the analgesic effect for injection site pain to compare the right eyelid with local anesthetics for 30 minutes and the left eyelid in BS patients who receive BTX-A for the first time at our hospital. Furthermore, in consecutive BS patients who received 5 or more times injections, we evaluate the analgesic effect in comparison with the past and this time with local anesthetics applied to both eyelids. Since a cure has yet to be found in BS, it is necessary to continue BTX-A treatment over a long period, and mental stress affect the medical condition, therefore, reduction of injection pain was an important issue. If analgesic effects of local anesthetics are demonstrated, patients who have extended the injection interval due to pain will be able to receive injections regularly, leading to amelioration of patient satisfaction for BTX treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale(VAS) score
First injection group: comparison with righ eye and left eye
consecutive group: comparison with the past and this time
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patinets with BTX therapy for the first time and consecutive patients with 5 or more times injection
Key exclusion criteria
past history of lid surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | osamu |
| Middle name | |
| Last name | Mimura |
Organization
Hyogo college of medicine hospital
Division name
Deoartment of Ophthalmology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6462
mimu@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kimura |
Organization
Hyogo college of medicine hospital
Division name
Deoartment of Ophthalmology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6462
Homepage URL
akis@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine hospital
Institute
Department
Personal name
Funding Source
Organization
Ministory of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo college of medicine hospital
Address
Nishinomiya city, mukogawa-cho 1-1
Tel
0798456111
akis@hyo-med.ac.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
| 2018 | Year | 10 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are 10 people in the first group and 70 in the cosecutive group, and we prepare to give a presentation at the annual meeting of the Japanese Ophthalmological Society in April 2019.
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039501
