UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031002 |
|---|---|
| Receipt number | R000035388 |
| Scientific Title | Comparison of ultrasound guided femoral nerve block and two places adductor canal block for postoperative analgesia after total knee arthroplasty |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2020/05/08 08:49:10 |
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Basic information
Public title
Comparison of ultrasound guided femoral nerve block and two places adductor canal block for postoperative analgesia after total knee arthroplasty
Acronym
Comparison of ultrasound guided femoral nerve block and two places adductor canal block for postoperative analgesia after total knee arthroplasty
Scientific Title
Comparison of ultrasound guided femoral nerve block and two places adductor canal block for postoperative analgesia after total knee arthroplasty
Scientific Title:Acronym
Comparison of ultrasound guided femoral nerve block and two places adductor canal block for postoperative analgesia after total knee arthroplasty
Region
| Japan |
Condition
Condition
patients receiving unilateral total knee arthroplasty
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare femoral nerve block and two places adductor canal block for influence on postoperative analgesia and rehabilitation after unilateral TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative 24h Range of Motion (ROM)
Key secondary outcomes
Postoperative Range of Motion (ROM)(12,24,48h,3d)
Postoperative NRS at rest (0,6,12,24,48h)
Postoperative NRS during knee movement (0,6,12,24,48h)
Postoperative effect of Sciatic nerve block (0,12,24h)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral nerve block
Interventions/Control_2
Femoral triangle block
Interventions/Control_3
Adductor canal block
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled unilateral total knee arthroplasty
Key exclusion criteria
history of complications
Patients who can not evaluate NRS
Patients with local anesthetics allergy
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Kudo |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL
0166682583
kyokui090018@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Kudo |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL
0166682583
Homepage URL
kyokui090018@gmail.com
Sponsor or person
Institute
Asahikawa Medical University
Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Anesthesiology and Critical Care Medicine
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 | 01 | Month | 25 | 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
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 02 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035388
