UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025488
Receipt number 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 19:14:56

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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 or person

Institute

St. marianna University school of Medicine

Institute

Department

Personal name



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

Value
https://center6.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