UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000031194