UMIN-CTR Clinical Trial

Basic information
Public title	Vascular diameter after femoral nerve block in patients with critical limb ischemia under general anesthesia
Acronym	Vascular diameter after femoral nerve block in patients with critical limb ischemia under general anesthesia
Scientific Title	Vascular diameter after femoral nerve block in patients with critical limb ischemia under general anesthesia
Scientific Title:Acronym	Vascular diameter after femoral nerve block in patients with critical limb ischemia under general anesthesia
Region	Japan

Condition
Condition	critical limb ischemia
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation whether vasodilation is provided by peripheral nerve block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Vascular diameter of bilateral great saphenous vein at three point of time.(preoperative examination, immediately before femoral nerve block, under general anesthesia after femoral nerve block)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Perform ultrasound femoral nerve block at operating side inguinal region before general anesthesia. Dose 0.2% levobupivacaine 20ml for femoral nerve block. Start introduction of general anesthesia after femoral nerve block. Measure diameter of great saphenous vein using ultrasound before FNB and after introduction of general anesthesia. Measure inner and vertical diameter of great saphenous vein at six points of lower limb from proximal to distal without tourniquet.
Interventions/Control_2	Measure them without femoral nerve block in non operating side.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Bilateral great saphenous vein are present and can be measured the diameter.
Key exclusion criteria	Non operating side lower limb had operation ,for example, bypass surgery and vein harvesting.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Yokokawa
Organization	Osaka Rosai Hospital
Division name	Department of anesthesiology
Zip code	591-8025
Address	1179-3,Nagasone-chou,kita-ku,Sakai-shi,Osaka
TEL	072-252-3561
Email	harutomorei@yahoo.co.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name Yokokawa
Organization	Osaka Rosai Hospital
Division name	Department of anesthesiology
Zip code	591-8025
Address	1179-3,Nagasone-chou,kita-ku,Sakai-shi,Osaka
TEL	072-252-3561
Homepage URL
Email	harutomorei@yahoo.co.jp

Sponsor
Institute	Osaka Rosai Hospital
Institute
Department

Funding Source
Organization	Osaka Rosai Hospital
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	Osaka Rosai Hospital Institutional Review Board
Address	1179-3,Nagasone-chou,kita-ku,Sakai-shi,Osaka
Tel	072-252-3561
Email	harutomorei@yahoo.co.jp

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	2022 Year 10 Month 29 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	11
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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 10 Month 28 Day
Anticipated trial start date	2019 Year 11 Month 25 Day
Last follow-up date	2021 Year 10 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	2022 Year 10 Month 29 Day
Last modified on	2022 Year 10 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050150