UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049364 |
|---|---|
| Receipt number | R000050150 |
| Scientific Title | Vascular diameter after femoral nerve block in patients with critical limb ischemia under general anesthesia |
| Date of disclosure of the study information | 2022/10/29 |
| Last modified on | 2022/10/29 12:14:46 |
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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
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
harutomorei@yahoo.co.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050150
