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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025344
Receipt No. R000029145
Scientific Title Effect of magnesium added to local anesthetics in caudal anesthesia on postoperative pain: A meta-analysis with trial sequential analysis
Date of disclosure of the study information 2017/01/15
Last modified on 2018/01/06

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Basic information
Public title Effect of magnesium added to local anesthetics in caudal anesthesia on postoperative pain: A meta-analysis with trial sequential analysis
Acronym Effect of magnesium added to local anesthetics in caudal anesthesia on postoperative pain: A meta-analysis with trial sequential analysis
Scientific Title Effect of magnesium added to local anesthetics in caudal anesthesia on postoperative pain: A meta-analysis with trial sequential analysis
Scientific Title:Acronym Effect of magnesium added to local anesthetics in caudal anesthesia on 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 magnesium is added to caudal anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes duration of analgesia
number of patients who required postoperative rescue analgesics
Key secondary outcomes 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: caudal magnesium 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 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0190354
Number of participants that the trial has enrolled
Results
There was no significant change in the number of patients who needed rescue analgesics after caudal administration of magnesium.
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 20 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
2017 Year 11 Month 20 Day
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 21 Day
Last modified on
2018 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029145

Research Plan
Registered date File name
2017/02/08 Study Protocol magnesium_003.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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