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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034343
Receipt No. R000039149
Scientific Title The analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block for hip fracture.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/10/01

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Basic information
Public title The analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block for hip fracture.
Acronym The analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block for hip fracture.
Scientific Title The analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block for hip fracture.
Scientific Title:Acronym The analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block for hip fracture.
Region
Japan

Condition
Condition femoral neck/trochanter fracture
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the analgesic efficacy and the effect on postoperative outcome of preoperative fascia iliaca block (FICB) for hip fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Elapsed time until first additional analgesia after surgery
Key secondary outcomes Perioperative NRS : before FICB and 1 hour, 6 hours, 12 hours and 24 hours after FICB
Frequency of preoperative complication

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 preoperative fascia iliaca block
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 Patients who will undergo femoral neck/trochanter fracture surgery.
Key exclusion criteria history of allergy to local anesthetic, multiple fracture patioents.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Ishioka
Organization Takikawa Municipal Hospital
Division name Department of Anesthesiology
Zip code
Address 2-2-34 Omachi, Takikawashi
TEL 0123-22-4311
Email 448ishioka@med.takikawa.hokkaido.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishioka Yoshiya
Organization Takikawa Municipal Hospital
Division name Department of Anesthesiology
Zip code
Address 2-2-34 Omachi, Takikawashi
TEL 0123-22-4311
Homepage URL
Email 448ishioka@med.takikawa.hokkaido.jp

Sponsor
Institute Takikawa Municipal Hospital
Institute
Department

Funding Source
Organization Takikawa Municipal 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
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 10 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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