UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004927 |
|---|---|
| Receipt number | R000005863 |
| Scientific Title | The youthfulness of Epidrum for identification of epidural space |
| Date of disclosure of the study information | 2011/01/24 |
| Last modified on | 2011/07/22 01:24:32 |
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Basic information
Public title
The youthfulness of Epidrum for identification of epidural space
Acronym
The youthfulness of Epidrum for identification of epidural space
Scientific Title
The youthfulness of Epidrum for identification of epidural space
Scientific Title:Acronym
The youthfulness of Epidrum for identification of epidural space
Region
| Japan |
Condition
Condition
elective surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Vascular surgery |
| Obstetrics and Gynecology | Orthopedics | Urology |
| Anesthesiology | Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of the ED for identification of the epidural space.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to locate the epidural space,the velocity of advancement of the needle,the score of the ease of identification of the epidural space with loss of resistance method using normal saline and with Epidrum by both the operator and the observer, and score of the operator satisfaction with identification of the epidural space with each methods.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
We use Epidrum in epidural anesthesia in ED group.
Interventions/Control_2
We use Loss of resistance method in epidural anesthesia in LOR group.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients underdo surgery with epidural anesthesia whose ASA pysical states 1 or 2.
Key exclusion criteria
Patients who have coagulopathy and/or degenerative spondylous disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamata Mikito |
Organization
Shinshu university school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
Address
asahi 3-1-1 matsumoto city nagano prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu university school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
Address
TEL
0263-37-2670
Homepage URL
Sponsor or person
Institute
Shinshu university school of medicine the department of anesthesiology and resuscitology
Institute
Department
Personal name
Funding Source
Organization
Shinshu university school of medicine the department of anesthesiology and resuscitology
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 01 | Month | 24 | 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
Suspended
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | 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
| 2011 | Year | 01 | Month | 21 | Day |
Last modified on
| 2011 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005863
