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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025488
Receipt No. R000029332
Scientific Title Study for postoperative pain control of continuous trans-catheter local anesthetic
Date of disclosure of the study information 2017/01/02
Last modified on 2016/12/31

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Basic information
Public title Study for postoperative pain control
of continuous trans-catheter local anesthetic

Acronym Study for postoperative pain control
of continuous trans-catheter local anesthetic

Scientific Title Study for postoperative pain control
of continuous trans-catheter local anesthetic

Scientific Title:Acronym 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
1st name
Middle name
Last name Souitro Inoue
Organization St. marianna University school of Medicine
Division name Anesthesiology
Zip code
Address Sugao 2-16-1 Miyamae Kawasaki
TEL 044-977-8111
Email ioues@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Obata
Organization St. marianna University school of Medicine
Division name Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 12 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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