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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018773
Receipt No. R000021717
Scientific Title Study on the spread of local anesthetic solution in rectus sheath block in the longitudinal direction
Date of disclosure of the study information 2015/08/23
Last modified on 2015/09/09

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Basic information
Public title Study on the spread of local anesthetic solution in rectus sheath block in the longitudinal direction
Acronym Study on the spread of local anesthetic solution in rectus sheath block
Scientific Title Study on the spread of local anesthetic solution in rectus sheath block in the longitudinal direction
Scientific Title:Acronym Study on the spread of local anesthetic solution in rectus sheath block
Region
Japan

Condition
Condition mid-line incision surgery of gastrointestinal
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a standard local anesthetic volume for RSB
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To measure on both sides of the spread of local anesthetics on caudally and cephalad.
Key secondary outcomes

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria over 20 years old and scheduled for mid-line incision surgery were recruited at Gunma University Hospital.
Key exclusion criteria 1)patient who did not have the block
2)patient who had an allergy to local anesthetics
3)patient who refused to join the study
4)patient who was judged as inadequite
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakajima Kunie
Organization Gunma University Hospital
Division name Anesthesiology
Zip code
Address 3-39-15 Showa, Maebashi, Gunma, Japan
TEL 027-220-8454
Email knkunie@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakajima
Organization Gunma University Hospital
Division name Anesthesiology
Zip code
Address 3-39-15 Shouwa, Mebashi, Gunma, Japan
TEL 0272208454
Homepage URL
Email knkunie@yahoo.co.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 08 Month 23 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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2015 Year 08 Month 23 Day
Last modified on
2015 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021717

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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