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
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
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
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
