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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033021
Receipt No. R000037644
Scientific Title Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/16

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Basic information
Public title Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Acronym Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Scientific Title Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Scientific Title:Acronym Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Anesthesiology Intensive care medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of thoracic epidural analgesia with local anesthetics on diaphragmatic function after laparoscopic gastrectomy using respiratory inductive plethysmography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes postoperative pain, diaphragmatic 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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 epidural analgesia
Interventions/Control_2 iv PCA
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patients underwent laparoscopic gastrectomy
2)ASA PS 1or 2
Key exclusion criteria 1)Patients' refusal to participate in clinical research
2)open abdominal surgery
3)general contraindications for epidural anaesthesia
4)patients with cardiorespiratory dysfunction
5)patients with liver of renal dysfunction
6)bleeding history, and regular medication interfering with blood coagulation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name NAOYUKI FUJIMURA
Organization St. Mary's Hospital
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
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
Institute
Department

Funding Source
Organization St. Mary's Hospital
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 YES
Study ID_1 14-0303
Org. issuing International ID_1 St. Mary's Hospital
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 06 Month 20 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
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 14 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 06 Month 16 Day
Last modified on
2018 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037644

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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