UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Title of the study (Brief title)	Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Region	Japan

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

Objectives
Narrative objectives1	postoperative pain management
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual analog scale after surgery number of dose in intravenous patient controlled analgesia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Maneuver
Interventions/Control_1	continuous epidural anesthesia + IV-PCA: group E
Interventions/Control_2	continuous thoracic paravertebral block + IV-PCA group: group T
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.ASA class:1.2.3 2.20 years of age or more 3.agree with clinical research
Key exclusion criteria	1.poor understanding for VAS 2.severe cardiac, renal dysfunction 3.severe liver dysfunction 4.poor controll diabetes[HbA1c>8.0, FBS>200mg/dl] 5.having local anesthetic allergy
Target sample size	80

Research contact person
Name of lead principal investigator	Hironobu UESHIMA
Organization	Saitama Medical University International Medical Center
Division name	Department of Anesthesiology
Address	1397-1 Yamane, Hidaka City, Saitama
TEL	042-984-4111
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	Hironobu Ueshima
Organization	Saitama Medical University International Medical Center
Division name	Department of Anesthesiology
Address	1397-1 Yamane, Hidaka City, Saitama
TEL	042-984-4111
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 07 Month 04 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013031