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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025099
Receipt No. 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

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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
Email 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
Email hiromasa.kawakami@nifty.com

Sponsor
Institute Kanagawa Children's Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028780

Research Plan
Registered date File name
2016/12/01 Study Protocol iv steroid_002.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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