UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial of Analgesic effect of epidural anesthesia and paravertebral block in pneumectomy
Title of the study (Brief title)	Analgesic effect of epidural anesthesia and paravertebral block - Randomized Controlled Trial -
Region	Japan

Condition
Condition	Case to undergo operation of lobectomy and lymphadenectomy with standerd thoracotomy
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We compare the analgesic effect between epidural anesthesia and paravertebral block after operation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual analog scale
Key secondary outcomes	drug blood concentration, blood pressure, pulse rate, SpO2, breathing number of times, complications, side effect, difference of kind and use frequency of the additional analgesic agent, length of stay Evaluation of postoperative chronic pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	epidural anethesia group
Interventions/Control_2	parabertebral block group
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA PS one or two age from twenty toseventy five years olds male and female The patient that a document agreement by the free will of a patient was provided
Key exclusion criteria	don't get agreement ASA, more than three interstitial pneumonia pulmonary fibrosis severe asthma pulmonary emphysema central nervous system disorder and peripheral nerve disorder coagulation disorder thrombocytopenia doing anticoagulation therapy sepsis infection of puncuture skin severe heart disease cirrhosis renal failure severe diabetes mellitus anemia allergy of local anesthesis maternal past history of same side thoracotomy risl of pleural adhesion pasy history of radiotherapy difficult anesthesia which was set of the Minister of Health, Labour and Welfare and, the patients who was judged that a trial entry was inappropriate
Target sample size	80

Research contact person
Name of lead principal investigator	Takahiro Tamura
Organization	Japanese Red Cross Nagoya Daiichi Hospital
Division name	Department of Anesthesia
Address	Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL	0524815111
Email	takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person	Takahiro Tamura
Organization	Japanese Red Cross Nagoya Daiichi Hospital
Division name	Department of Anesthesia
Address	Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL	0524815111
Homepage URL
Email	takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Nagoya Daiishi Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesia, Japanese Red Cross Nagoya Daiichi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 19 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 07 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011894