UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034343 |
|---|---|
| Receipt number | 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 | 2020/10/06 11:41:27 |
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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
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
448ishioka@med.takikawa.hokkaido.jp
Sponsor or person
Institute
Takikawa Municipal Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039149
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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