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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014599
Receipt No. R000016986
Scientific Title The Comparison of Epidural Anesthesia and Peripheral Nerve Block for Total Knee Arthroplasty
Date of disclosure of the study information 2014/07/24
Last modified on 2014/07/20

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Basic information
Public title The Comparison of Epidural Anesthesia and Peripheral Nerve Block for Total Knee Arthroplasty
Acronym Epidural Anesthesia or Peripheral Nerve Block for Total Knee Arthroplasty
Scientific Title The Comparison of Epidural Anesthesia and Peripheral Nerve Block for Total Knee Arthroplasty
Scientific Title:Acronym Epidural Anesthesia or Peripheral Nerve Block for Total Knee Arthroplasty
Region
Japan

Condition
Condition osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of adding epidural anesthesia or peripheral nerve block in patients who undergo total knee arthroplasty in general anesthesia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain, nausea and vomiting and ambulation in 1st, 2nd, 3rd and 7th post operative day
Key secondary outcomes

Base
Study type

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 Maneuver
Interventions/Control_1 general anesthesia + epidural anesthesia
Interventions/Control_2 general anesthesia + peripheral nerve block
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for total knee arthroplasty.
Written informed consents are obtained from all the patients.
Key exclusion criteria Patients who have reduced platelet counts or platelet disfunction.
Patients who have coagulation disorder.
Patients who take anti-platelet drug or anti-coagulant drug or who are heparinized during perioperative period.
Patients who have allergy or intolerance to one of the study drugs.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOMIOKA, Toshiya
Organization Saitama Red Cross Hospital
Division name department of anesthesiology
Zip code
Address 8-3-33, Kamiotiai, Chuo-ku, Saitama-shi, Saitama
TEL 048-852-1111
Email ttomioka-ns@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MUTO, Yoshinori
Organization Saitama Red Cross Hospital
Division name department of anesthesiology
Zip code
Address 8-3-33, Kamiotiai, Chuo-ku, Saitama-shi, Saitama
TEL 048-852-1111
Homepage URL
Email yosshymuto@hotmail.com

Sponsor
Institute Saitama Red Cross Hospital
Institute
Department

Funding Source
Organization Saitama Red Cross Hospital
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
2014 Year 07 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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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
2014 Year 07 Month 20 Day
Last modified on
2014 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016986

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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