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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028338
Receipt No. R000031194
Scientific Title Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients.
Date of disclosure of the study information 2017/08/10
Last modified on 2019/08/14

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Basic information
Public title Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients.
Acronym Examination of the analgesic method for the thoracic surgery operation.
Scientific Title Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients.
Scientific Title:Acronym Examination of the analgesic method for the thoracic surgery operation.
Region
Japan

Condition
Condition Lung cancer, pulmonary metastasis, pulmonary benign tumor
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination of the valid sedative method after the breast procedures for the patients during an anticoagulant therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes NRS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 peripheral nerve block
We detain peridural catheter before induction of anaesthesia in all cases.
We introduce a general anesthesia and perform a nerve block after having established an operative position.
As supporting analgesia, a fentanyl constant infusion is provided and uses the epidural anesthesia only at pain control distress after the next day.
We measure as a pain evaluation using nrs for 2, 4, 6,12,24,36,48 hours after surgery.
We measure before and after an operation about the presence or absence of stress hormone discharge in nerve block group.
Interventions/Control_2 epidulal
We implant peridural catheter similar to nerve block group and introduce a general anesthesia.
We start the administration of local anesthetics at peridural catheter during an operation.
The supporting analgesic is carried out similar to nerve block group.
The pain evaluation is carried out similar to nerve block group, too.
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 video-assisted mini-thoracotomy
Key exclusion criteria drug allergy
bleeding tendency
intenshion of the patient
analgesic addict
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masako Yamamoto
Organization Kawasaki Medical School
Division name anesthesiology
Zip code
Address 577Matushima Kurashiki-City Okayama
TEL 086-464-1111
Email masakok319791008@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masako Yamamoto
Organization Kawasaki Medical School
Division name anesthesiology
Zip code
Address 577Matushima Kurashiki-City Okayama
TEL 086-4-464-1111
Homepage URL
Email masakok319791008@yahoo.co.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 08 Month 10 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 16
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 08 Month 10 Day
Date of IRB
2017 Year 09 Month 27 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 15 Day
Date analysis concluded
2019 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 23 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031194

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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