UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033860 |
|---|---|
| Receipt number | R000038611 |
| Scientific Title | Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in suplaclavicular and interscalene brachial plexus block for pediatric postoperative analgesia. |
| Date of disclosure of the study information | 2018/08/22 |
| Last modified on | 2018/08/22 20:32:25 |
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Basic information
Public title
Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in suplaclavicular and interscalene brachial plexus block for pediatric postoperative analgesia.
Acronym
Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in suplaclavicular and interscalene brachial plexus block for pediatric postoperative analgesia.
Scientific Title
Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in suplaclavicular and interscalene brachial plexus block for pediatric postoperative analgesia.
Scientific Title:Acronym
Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in suplaclavicular and interscalene brachial plexus block for pediatric postoperative analgesia.
Region
| Japan |
Condition
Condition
Pediatric patients given brachial plexus block
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the hypothesis that adding dexamethasone to ropivacaine significantly prolongs the duration of analgesia in brachial plexus block compared with ropivacaine alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence and strength of pain within 24 hours after surgery
Key secondary outcomes
The time until the analgesic drug is used for the first time, and the pain score at that time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control(ropivacaine only)
Interventions/Control_2
Add dexamethasone to ropivacaine
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients undergoing elective upper limb surgeries using general anesthesia and echo guided brachial plexus block.
Key exclusion criteria
history of allergic reaction to study drugs, infection at brachial plexus block site
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Kotera |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Anesthesia
Zip code
Address
2-10-39 Shibata Kitaku Osaka City
TEL
0663720333
koolinaare@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Kotera |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Anesthesia
Zip code
Address
2-10-39 Shibata Kitaku Osaka City
TEL
0663720333
Homepage URL
koolinaare@gmail.com
Sponsor or person
Institute
Aoki surgery orthopedic hospital
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
Address
Tel
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 | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
