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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024147
Receipt No. R000027805
Scientific Title Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Date of disclosure of the study information 2016/09/24
Last modified on 2018/03/28

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Basic information
Public title Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Acronym Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Scientific Title Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Scientific Title:Acronym Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Region
Japan

Condition
Condition proximal femoral fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the postoperative analgesic efficacy of intravenous acetaminophen and fascia iliaca compartment block for patients with proximal femoral fracture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain (until 7days after surgery.)
Key secondary outcomes the number of rescue dose.
All side effects.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Medicine
Interventions/Control_1 intravenous acetaminophen
6 and 12 hours after surgery
Interventions/Control_2 Fascia iliaca compartment blockade
before spinal anesthesia
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 The patients whose American Society of Anesthesiologists Physical Status are 1-2, planned to perform surgery for proximal femoral fracture.

a person who was informed sufficiently, and agree to perticipate this study of one's free will.
Key exclusion criteria peripheral neuropathy or local anesthetic allergy.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Danura
Organization Unnan City Hospital
Division name Department of Orthopedic Surgery
Zip code
Address 96-1 Daito-cho Iida, Unnan, Shimane, 699-1221, Japan
TEL +81-85-443-2390
Email tomocalcio@blackmail.cn

Public contact
Name of contact person
1st name
Middle name
Last name Norio Yamamoto
Organization Unnan City Hospital
Division name Department of Orthopedic Surgery
Zip code
Address 96-1 Daito-cho Iida, Unnan, Shimane, 699-1221, Japan
TEL +81-85-443-2390
Homepage URL
Email norio-yamamoto@umin.ac.jp

Sponsor
Institute Unnan City Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 09 Month 24 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 Completed
Date of protocol fixation
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 26 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
2016 Year 09 Month 24 Day
Last modified on
2018 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027805

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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