UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019006 |
|---|---|
| Receipt number | R000021984 |
| Scientific Title | Difference of cross-sectional sonoanatomy and the effects in three ultrasound-guided lumbar plexus block |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/02/08 09:23:53 |
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Basic information
Public title
Difference of cross-sectional sonoanatomy and the effects in three ultrasound-guided lumbar plexus block
Acronym
cross-sectional sonoanatomy ultrasound-guided lumbar plexus block
Scientific Title
Difference of cross-sectional sonoanatomy and the effects in three ultrasound-guided lumbar plexus block
Scientific Title:Acronym
cross-sectional sonoanatomy ultrasound-guided lumbar plexus block
Region
| Japan |
Condition
Condition
Degenerative hip disease
Avascular necrosis of the femoral head
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare three ultrasound-guided (USG) lumbar plexus block from the aspect of the difference of sonoanatomic quality and the effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound visibility of the lumbar paravertebral structures, needle, deposited local anesthetics, and inserted catheter
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for total hip arthroplasty received an ultrasound-guided lumbar plexus block
Key exclusion criteria
Patients who have history of surgery on lumbar or hip area, deformity of bone or muscles in lumbar or hip area, pre-existing sensory or motor dysfunction on lumbar or sacral plexus teritory
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sato |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa,Japan
TEL
0166-68-2583
satomako@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sato |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa,Japan
TEL
0166-68-2583
Homepage URL
satomako@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ultrasound visibility of the lumbar paravertebral structures, needle, deposited local anesthetics, and inserted catheter were assessed by independent observers using a 4-point Likert scale and by a luminance analysis software; Image J (National Institute of Health).
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021984
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
