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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030686
Receipt No. R000035035
Scientific Title The ultrasound-guided erector spinae plane block using programmed intermittent bolus infusion after video-assisted thoracoscopic lobectomy: A preliminary case series.
Date of disclosure of the study information 2018/01/05
Last modified on 2019/01/06

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Basic information
Public title The ultrasound-guided erector spinae plane block using programmed intermittent bolus infusion after video-assisted thoracoscopic lobectomy: A preliminary case series.
Acronym A preliminary case series of the ultrasound-guided erector spinae plane block
Scientific Title The ultrasound-guided erector spinae plane block using programmed intermittent bolus infusion after video-assisted thoracoscopic lobectomy: A preliminary case series.
Scientific Title:Acronym A preliminary case series of the ultrasound-guided erector spinae plane block
Region
Japan

Condition
Condition Lung tumor
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 we performed preliminary case series of PIB injection for US-ESPB in thoracoscopic lobectomy to verify the analgesic effectiveness and feasibility.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS on movement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Ultrasound-guided erector spinae block
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Provided written informed consent
2.American Society of Anesthesiologists physical status 1-3
3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung tumor.
Key exclusion criteria Allergy to local anesthetics
BMI>40
Age< 20 or >86
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Fujitani
Organization Ehime Prefectural Central Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL +81-89-947-1111
Email suko1231@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Taketa
Organization Ehime Prefectural Central Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL +81-89-947-1111
Homepage URL
Email suko1231@yahoo.co.jp

Sponsor
Institute Ehime Prefectural Central Hospital
Institute
Department

Funding Source
Organization Ehime Prefectural Central 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
2018 Year 01 Month 05 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
2017 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2019 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=R000035035

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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