UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021880 |
|---|---|
| Receipt number | R000025228 |
| Scientific Title | Is an ultrasound-guided thoracolumbar interfacial plane (TLIP) block effective for lumbar spine surgery? |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2017/04/12 06:28:03 |
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Basic information
Public title
Is an ultrasound-guided thoracolumbar interfacial plane (TLIP) block effective for lumbar spine surgery?
Acronym
Clinical experiences of ultrasound-guided TLIP block
Scientific Title
Is an ultrasound-guided thoracolumbar interfacial plane (TLIP) block effective for lumbar spine surgery?
Scientific Title:Acronym
Clinical experiences of ultrasound-guided TLIP block
Region
| Japan | Asia(except Japan) |
Condition
Condition
Lumbar spine surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An efficacy of TLIP block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
an additional amount of analgesic
Key secondary outcomes
VAS score (at rest and at movement)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group with TLIP block
Interventions/Control_2
A group with saline
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lumbar spine surgery
Key exclusion criteria
secondary surgery
spine surgery of more than 3 intervertebral space
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa University Hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
ueshimhi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIronobu Ueshima |
Organization
Showa University Hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
Homepage URL
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Showa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
大阪府
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 13 | 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
| 2016 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2017 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025228
