UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011166 |
|---|---|
| Receipt number | R000013078 |
| Scientific Title | A comparison of continuous epidural block with continuous ultrasound-guided femoral nerve block for total knee arthroplasty |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2013/07/10 20:29:27 |
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Basic information
Public title
A comparison of continuous epidural block with continuous ultrasound-guided femoral nerve block for total knee arthroplasty
Acronym
Epidural or femoral block after knee arthroplasty.
Scientific Title
A comparison of continuous epidural block with continuous ultrasound-guided femoral nerve block for total knee arthroplasty
Scientific Title:Acronym
Epidural or femoral block after knee arthroplasty.
Region
| Japan |
Condition
Condition
gonarthrosis; osteoarthritis of the knee
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the perioperative quality of anesthesia, analgesia, activities of daily living, and complications for total knee arthroplasty (TKA) using either epidural analgesia (EA) or ultrasound-guided continuous femoral nerve block (FNB).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compared the total doses of fentanyl and ropivacaine administered during surgery, and also evaluated complications and postoperative pain using a Visual Analogue Scale (VAS) at rest and during movement for the first 3 postoperative days (PODs).
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are 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 block
Interventions/Control_2
General anesthesia+femoral nerve bock
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
After obtaining institutional ethics committee approval (Saitama Social Insurance Hospital, #112, 12 October 2007, patients scheduled to undergo primary TKA were invited to participate in the study. Written informed consent was obtained from all study subjects.
Key exclusion criteria
Exclusion criteria included the following: inability to give informed consent for language or cognitive reasons; contraindications for neuraxial blockade, including patient refusal and platelet count of <100,000 cells.ul-1; contraindications for epidural block, such as current therapy with anticoagulant drugs or infection overlying the proposed injection site; and contraindications to any of the study drugs.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuharu Kodaka |
Organization
Tokyo Women's Medical University, School of Medicine Medical Center East
Division name
Department of Anesthesiology
Zip code
Address
2-1-10 Arakawa-ku, Tokyo 116-8567, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MITSHARU KODAKA |
Organization
Tokyo Women's Medical University, School of Medicine, Medical Center East
Division name
Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
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
| 2013 | Year | 07 | Month | 10 | 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
| 2007 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | 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
| 2013 | Year | 07 | Month | 10 | Day |
Last modified on
| 2013 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013078
