UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pressure measurement of needle tip while performing ultrasound-guided thoracic paravertebral block
Title of the study (Brief title)	Needle tip pressure measurement in thoracic paravertebral block
Region	Japan

Condition
Condition	Patients who undergo elective thoracic surgery under unilateral thoracotomy with paravertebral catheter insertion
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To show the pressure differense between intercostal muscle and paravertebral space as to indicate successful block when performing ultrasound-guided thoracic paravertebral block with intercostal transverse parallel approach.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Needle tip pressure difference when it places in intercostal muscle and paravertebral space
Key secondary outcomes	Factors which affect the pressure difference

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Adult patients who undergo elective thoracic surgery under unilateral thoracotomy and to whom paravertebral catheter insertion was planned
Key exclusion criteria	Patients who did not or could not sign the written informed consent by themselves In case the anesthesiologist who was not related to the study judged that the needle tip was not situated appropriately in the intercostal space or paravertebral spac in saved ultrasound image at the pressure measurement
Target sample size	40

Research contact person
Name of lead principal investigator	Kenta Okitsu
Organization	Osaka university graduate school of medicine
Division name	Department of anesthesiology and intensive care medicine
Address	Yamadaoka 2-2, Suita, Osaka
TEL	+81668793133
Email	kokitsu@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Kenta Okitsu
Organization	Osaka university graduate school of medicine
Division name	Department of anesthesiology and intensive care medicine
Address	Yamadaoka 2-2, Suita, Osaka
TEL	+81668793133
Homepage URL
Email	kokitsu@anes.med.osaka-u.ac.jp

Sponsor
Institute	Department of anesthesiology and intensive care medicine, Osaka university graduate school of medicine
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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study includes all the patients undergoing thoracic or abdominal surgery under general anesthesia in Osaka University Hospital between 15th Feb 2016 and 31th Mar 2017 who fit for the study criteria. There is no group division. This is a prospective observational study which is aimed to reveal the change of the needle tip pressure when it is advanced to paravertebral space from intercostal muscle in performing thoracic paravertebral block.

Management information
Registered date	2016 Year 02 Month 14 Day
Last modified on	2017 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024028