UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025099 |
|---|---|
| Receipt number | R000028780 |
| Scientific Title | Effect of intravenous steroid added to caudal local anesthetics in improving postoperative pain: A meta-analysis with trial sequential analysis |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2017/11/23 00:36:29 |
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Basic information
Public title
Effect of intravenous steroid added to caudal local anesthetics in improving postoperative pain: A meta-analysis with trial sequential analysis
Acronym
Effect of intravenous steroid added to caudal local anesthetics in improving postoperative pain: A meta-analysis with trial sequential analysis
Scientific Title
Effect of intravenous steroid added to caudal local anesthetics in improving postoperative pain: A meta-analysis with trial sequential analysis
Scientific Title:Acronym
Effect of intravenous steroid added to caudal local anesthetics in improving postoperative pain: A meta-analysis with trial sequential analysis
Region
| Japan |
Condition
Condition
surgical patients who received caudal analgesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the duration of caudal local anesthesia is prolonged if intravenous steroid is given.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
duration of analgesia
Key secondary outcomes
the number of patients who required rescue analgesia
postoperative pain scale
duration of motor block
adverse events
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Randomized control trials including following PICO
Patients: surgical patients receiving caudal analgesia
Intervention and control: intravenous steroid and placebo
Outcome: postoperative pain
Key exclusion criteria
case reports, reviews, manikin studies, and animal studies. Eligibility is not restricted by language
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kawakami |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa Minamiku Yokohama Kanagawa
TEL
045-711-2351
hiromasa.kawakami@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kawakami |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa Minamiku Yokohama Kanagawa
TEL
045-711-2351
Homepage URL
hiromasa.kawakami@nifty.com
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Children's Medical Center
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/anesthesia-analgesia/Abstract/2017/12000/Effect_of_an_Intravenous_Dexamethas
Number of participants that the trial has enrolled
Results
6 randomized clinical trials were identified. Analgesic duration of caudal anethesia is longer by approximately 4 hours in patients who received intravenous dexamethasone
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 | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the details of the study protocol are presented in the attached files
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028780
