UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for postoperative pain control of continuous trans-catheter local anesthetic
Title of the study (Brief title)	Study for postoperative pain control of continuous trans-catheter local anesthetic
Region	Japan

Condition
Condition	cardiac valve diseade
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the analgesic effect after surgery by performing continuous infiltration anesthesia of the wound using porous catheter. Observe whether a superior analgesic effect can be obtained because the local anesthetic infiltrates throughout the wound by using a porous catheter.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	assessment of postoperative analgesia score (NRS)
Key secondary outcomes	postoperative blood pressure, heart rate, SpO 2, time to leave, length of stay in hospital, presence of cardiovascular complications, respiratory complications With or without

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	0.25% levobupivacaine at 4 ml / h using a porous catheter, continuous administration until the first day after surgery on the wound site
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient scheduled to undergo catheterization using a transapical apical approach with agreement before surgery
Key exclusion criteria	Local anesthetic drug allergy
Target sample size	100

Research contact person
Name of lead principal investigator	Souitro Inoue
Organization	St. marianna University school of Medicine
Division name	Anesthesiology
Address	Sugao 2-16-1 Miyamae Kawasaki
TEL	044-977-8111
Email	ioues@marianna-u.ac.jp

Public contact
Name of contact person	Yumi Obata
Organization	St. marianna University school of Medicine
Division name	Anesthesiology
Address	Sugao 2-16-1 Miyamae Kawasaki
TEL	044-977-8111
Homepage URL
Email	y2obata@marianna-u.ac.jp

Sponsor
Institute	St. marianna University school of Medicine
Institute
Department

Funding Source
Organization	St. marianna University school of Medicine
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 01 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 30 Day
Anticipated trial start date	2017 Year 01 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	2016 Year 12 Month 31 Day
Last modified on	2016 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029332