UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block
Acronym	Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block
Scientific Title	Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block
Scientific Title:Acronym	Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block
Region	Japan

Condition
Condition	femoral nerve block
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is possible to use femoral nerve block with injection pressure of 0-15 PSI by simple continuous injection pressure measurement method
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	percentage of completion of local anesthesic injection within target pressure range
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The dose of local anesthetic is set to 5 ml once, and a total of three measurements are made for each patient. Calculate the maximum injection pressure during each medical solution from the compression rate of the recorded air. When air compression indicating 15 PSI or more is confirmed, administration of chemical solution is promptly stopped after checking the injection pressure at that time. Change the puncture position to continue nerve block, measure subsequent injection pressures up to 3 times.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult patients undergoing orthpedic surgery for femoral fractures or pattella fracture. patients with sufficient understanding and consent after receiving an explanation of injection pressure measurement at the femoral nerve block
Key exclusion criteria	patients whose neurological block was judged inappropriate by the attending physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Kondo
Organization	Higashihiroshima medical center
Division name	department of anesthesiology
Zip code
Address	513, Saijyocho Jike, Higashihiroshima-shi,Hiroshima,739-0041,Japan
TEL	0824232176
Email	h.kondo1986@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Kondo
Organization	Higashihiroshima medical center
Division name	department of anesthesiology
Zip code
Address	513, Saijyocho Jike, Higashihiroshima-shi,Hiroshima,739-0041,Japan
TEL	0824232176
Homepage URL
Email	h.kondo1986@gmail.com

Sponsor
Institute	Higashihiroshima medical center
Institute
Department

Funding Source
Organization	Higashihiroshima medical center
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 05 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	2018 Year 03 Month 03 Day
Date of IRB	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 05 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 03 Day
Last modified on	2019 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035857