UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Title of the study (Brief title)	Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of paravertebral block for postoperative analgesia and the different effect depend on the medication method of paravertebral block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total amount of fentanyl which was injected by IV-PCA after the surgery
Key secondary outcomes	The change of plasma concentration of regional anesthetic agents in both groups.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.25% levobupivacaine or 0.2% ropivacaine will be given after the surgery through the catheter of paravertebral block. 16 ml of a local anesthetic will be given every 8 hours until 48 hour after the surgery in a group of intermittently medication method.
Interventions/Control_2	0.25% levobupivacaine or 0.2% ropivacaine will be given after the surgery through the catheter of paravertebral block. A local anesthetic was given with 6ml/hr until 48 hour after the surgery in a group of continuous medication method.
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	Patients of ASA physical status 1 or 2 scheduled for thoracoscopic lung lobectomy
Key exclusion criteria	1.Patients of ASA physical status 3 or 4. 2.Patients undergoing artifical dialysis. 3.Patients with hepatic failure. 4.Patients with infection 5.Patients with heart failur (NYHA 3 or 4) 6.patients with a pacemaker because of arrhythmia.
Target sample size	30

Research contact person
Name of lead principal investigator	Takahashi Keiya
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Address	2-1-1-1 Midorigaoka-higashi,Asahikawa,Hokkaido,Japan
TEL	0166652111
Email	k2341@asahikawa-med.ac.jp

Public contact
Name of contact person	Takahashi Keiya
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Address	2-1-1-1 Midorigaoka-higashi,Asahikawa,Hokkaido,Japan
TEL	0166652111
Homepage URL
Email	k2341@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Not applicable
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	2017 Year 04 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 22 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2015 Year 04 Month 01 Day
Date of closure to data entry	2015 Year 04 Month 01 Day
Date trial data considered complete	2015 Year 04 Month 02 Day
Date analysis concluded	2015 Year 04 Month 06 Day

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

Management information
Registered date	2017 Year 04 Month 03 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030806