UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014599 |
|---|---|
| Receipt number | 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 | 2020/07/25 15:17:59 |
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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
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
yosshymuto@hotmail.com
Sponsor or person
Institute
Saitama Red Cross Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016986
