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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029352
Receipt No. R000033545
Scientific Title Effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery
Date of disclosure of the study information 2017/09/29
Last modified on 2017/09/29

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Basic information
Public title Effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery
Acronym Effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery
Scientific Title Effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery
Scientific Title:Acronym Effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery
Region
Japan

Condition
Condition Patients underwent thoracic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of ultrasound-guided nerve block on postoperative pain after thoracic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS(NRS), respiratory function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epidural block with ropivacaine
Interventions/Control_2 ultrasound-guided paravertebral block with ropivacaine
Interventions/Control_3 ultrasound-guided retrolaminar block with ropivacaine
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria American society of Anesthesiologists (ASA) I-II
Key exclusion criteria 1)The patient consent cannot be obtained
2)ASA over III
3)Patients without surgery
4)Reoperation during the same
hospitalization
5) Patients with severe pulmonary or cardiac disorder
6) Patients with severe hepatic or renal disorder
7) Contraindications for epidural analgesia
8) Patients that judged to be inappropriate as a subject
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Fujimura
Organization St. Mary's Hospital
Our Lady of the Snow Social Medical Corporation
Division name Department of anesthesiology
Zip code
Address 422 Tsubukuhonmachi, Kurume, Fukuoka
TEL 0942-35-3322
Email n-fujimura@st-mary-med.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Fujimura
Organization St. Mary's Hospital Our Lady of the Snow Social Medical Corporation
Division name Department of anesthesiology
Zip code
Address 422 Tsubukuhonmachi, Kurume, Fukuoka
TEL 0942-35-3322
Homepage URL
Email n-fujimura@st-mary-med.or.jp

Sponsor
Institute St. Mary's Hospital
Our Lady of the Snow Social Medical Corporation
Institute
Department

Funding Source
Organization St. Mary's Hospital
Our Lady of the Snow Social Medical Corporation
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
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 09 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 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
2017 Year 09 Month 29 Day
Last modified on
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033545

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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