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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019577
Receipt No. R000022634
Scientific Title Study of drug effects on upper limb fractures post-operative pain
Date of disclosure of the study information 2015/11/01
Last modified on 2018/11/07

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Basic information
Public title Study of drug effects on upper limb fractures post-operative pain
Acronym Study of drug effects on upper limb fractures post-operative pain
Scientific Title Study of drug effects on upper limb fractures post-operative pain
Scientific Title:Acronym Study of drug effects on upper limb fractures post-operative pain
Region
Japan

Condition
Condition Patients undergoing surgery of the radial fracture under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analgesic effect in perioperative period
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pain evaluation performed by visual analog scale (VAS) after 3 hours and 24 hours postoperatively.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group that oral administration of pregabalin 75 mg before general anesthesia introduction 2 hours.
Interventions/Control_2 The group is not oral administration of pregabalin 75 mg before general anesthesia introduction 2 hours
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligible patients meet the criteria of American Society of Anesthesiologists(ASA)physical status of I-II.
Key exclusion criteria Patients are excluded the criteria of American Society of Anesthesiologists(ASA)physical status of over III.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadatoshi Muratani
Organization Rakusai Shimizu hospital
Division name department of anesthesiology
Zip code
Address 13-107 Oekutukake-machi nisikyo-ku,Kyoto city
TEL 075-331-8778
Email muratani@zj8.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadatoshi Muratani
Organization Rakusai Shimizu hospital
Division name department of anesthesiology
Zip code
Address 13-107 Oekutukake-machi nisikyo-ku,Kyoto city
TEL 075-331-8778
Homepage URL http://www.shimizu-hospital.or.jp/rakusai/
Email rakusai-iji@shimizu-hospital.or.jp

Sponsor
Institute Tadatoshi Muratani
Institute
Department

Funding Source
Organization Rakusai Shimizu hospital
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
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
2015 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 11 Month 22 Day
Date of closure to data entry
2016 Year 11 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 22 Day
Date analysis concluded
2018 Year 05 Month 02 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 30 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022634

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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