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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021880
Receipt No. 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

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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
Last 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
Email ueshimhi@yahoo.co.jp

Public contact
1st 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
Email ueshimhi@yahoo.co.jp

Sponsor
Institute Showa University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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