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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032571
Receipt No. R000035044
Scientific Title Ropivacaine plasma levels following nerve block on thoracic plane.
Date of disclosure of the study information 2018/05/14
Last modified on 2019/05/22

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Basic information
Public title Ropivacaine plasma levels following nerve block on thoracic plane.
Acronym Plasma concentration of ropivacaine after nerve block on thoracic wall.
Scientific Title Ropivacaine plasma levels following nerve block on thoracic plane.
Scientific Title:Acronym Plasma concentration of ropivacaine after nerve block on thoracic wall.
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 There are some reports which showed the pharmacokinetics of local anesthetics after abdominal wall block, but no report following chest wall. The purpose of this study is to evaluate the maximum total and ropivacaine concentrations and corresponding maximum times of plasma ropivacaine concentration after nerve blocks for chest wall.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Plasma ropivacaine concentration
The timings of sampling are 2.5,5,10,15,30,45,60,90,120min after peripheral nerve block.
Key secondary outcomes Clinical symptom of local anesthetic toxicity

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 Female
Key inclusion criteria elective surgery of breast cancer
Key exclusion criteria 1)under 20 years old
2)Hard to communication
3)Unable to establish the informed consent
4)Hepatic dysfunction
5)Renal dysfunction
6)serum albumin under 3.0g/dl
7)Allergy to amid type local anesthetic
8)Medication of antiarrysmitic drug
9)Medication of anticoagulants/anti-plateletdrug
10)Coagulopathy PT-INR >1.5
11)Any other confition whitch treated as contraindication of peripheral nerve blck
Target sample size 16

Research contact person
Name of lead principal investigator
1st name AKIHITO
Middle name
Last name KAKINUMA
Organization Teikyo university shcool of medicine hospital
Division name Anesthesia
Zip code 1738606
Address Kaga 2-11-1 Itabashi-ku Tokyo
TEL 0339641211
Email icg02177@nifty.com

Public contact
Name of contact person
1st name Akihito
Middle name
Last name Kakinuma
Organization Teikyo university shcool of medicine hospital
Division name Anesthesisa
Zip code 1738606
Address Kaga 2-11-1 Itabashi-ku Tokyo
TEL 0339641211
Homepage URL
Email icg02177@nifty.com

Sponsor
Institute Teikyo university school of medicine
Anesthetic department
Institute
Department

Funding Source
Organization Medeical office research expenses
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Teikyo univesity
Address Kaga2-11-1 Itabashi-ku Tokyo Japan
Tel 0339647256
Email turb-office@teikyo-u.ac.jp

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 帝京大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prepareing the study

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035044

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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