UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027277 |
|---|---|
| Receipt number | R000031254 |
| Scientific Title | The minimum effective anesthetic volume of 0.25% ropivacaine in Ultrasound-guided supra-inguinal fascia iliaca block |
| Date of disclosure of the study information | 2017/05/09 |
| Last modified on | 2021/05/12 15:35:20 |
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Basic information
Public title
The minimum effective anesthetic volume of 0.25% ropivacaine in Ultrasound-guided supra-inguinal fascia iliaca block
Acronym
Local anesthetic volume required for nerve block
Scientific Title
The minimum effective anesthetic volume of 0.25% ropivacaine in Ultrasound-guided supra-inguinal fascia iliaca block
Scientific Title:Acronym
Local anesthetic volume required for nerve block
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the 50% effective local anesthetics volume required for ultrasound guided supra inguinal Fascia iliaca compartment block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absent or existence of the laterality of the sense in the territory of femoral nerve and lateral cutaneous nerve.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hip fracture
Key exclusion criteria
infection of block site, allergy to local anesthetic. Diabetes mellitus, neuropathies, and patients receiving opioids for chronic pain
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Yamada |
Organization
Tsukuba gakuen hospital
Division name
Department of anesthesiology
Zip code
3050854
Address
Tsukuba city, ibaraki
TEL
09091422118
kumi5597@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | yamada |
Organization
Tsukuba gakuen hospital
Division name
Department of anesthesilogy
Zip code
3050854
Address
Tsukuba city,ibaraki
TEL
09091422118
Homepage URL
kumi5597@yahoo.co.jp
Sponsor or person
Institute
Tsukuba gakuen hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukuba gakuen 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
tsukuba gakuen hospital
Address
ibarakiken tsukubashi kamiyokoba 2573-1
Tel
09091422118
kumi5597@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
| 2017 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-020-79059-7
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-79059-7
Number of participants that the trial has enrolled
21
Results
EV50 and EV95 of 0.25% ropivacaine for ultrasound-guided supra-inguinal FICB calculated with logistic regression analysis were 15.01 ml (95% confidence interval, 6.53-22.99 ml) and 26.99 ml (95% confidence interval, 20.54-84.09 ml), respectively. EV50 and EV95 of 0.25% ropivacaine for ultrasound-guided supra-inguinal FICB were 15.01 ml and 26.99 ml, respectively.
Results date posted
| 2021 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study examined patients undergoing surgery for hip fracture.
Participant flow
This study examined patients undergoing surgery for hip fracture.
Adverse events
no adverse event.
Outcome measures
The 50% effective volume and the 95% effective volume of 0.25% ropivacaine for ultrasound-guided supra-inguinal fascia iliaca compartment block.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
random sample
Management information
Registered date
| 2017 | Year | 05 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031254
