UMIN-CTR Clinical Trial

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
Email	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
Email	kumi5597@yahoo.co.jp

Sponsor
Institute	Tsukuba gakuen hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031254