UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018092 |
|---|---|
| Receipt number | R000020942 |
| Scientific Title | Femoral nerve articular branch block:it's efficacy in pain relief for elderly patients after hip arthroplasty |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2016/04/03 13:23:00 |
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Basic information
Public title
Femoral nerve articular branch block:it's efficacy in pain relief for elderly patients after hip arthroplasty
Acronym
Femoral nerve articular branch block:it's efficacy in pain relief for elderly patients after hip arthroplasty
Scientific Title
Femoral nerve articular branch block:it's efficacy in pain relief for elderly patients after hip arthroplasty
Scientific Title:Acronym
Femoral nerve articular branch block:it's efficacy in pain relief for elderly patients after hip arthroplasty
Region
| Japan |
Condition
Condition
proximal femoral fractures
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Proximal femoral fractures are more common in elderly people. Severe pain may lead to delirium and delay the recovery. Therefore, The purpose of this study was to assess the effectiveness of femoral nerve of articular branch.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FRS(Face Rating Scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral nerve of articular branch block
Interventions/Control_2
None
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose American Society of Anesthesiologists Physical Status are 1-3, planned to hip arthroplasty and agree to Femoral nerve of articular branch block for postoperative analgesia are enrolled in this study.
Key exclusion criteria
Exclude criteria are the patients who have local anesthetic allergy or peripheral neuropathy or coagulation abnormality liver dysfunction(child-pugh score>B), renal dysfunction (eGFR<60).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Sugiura |
Organization
National hospital organization Tokyo Medical Center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902
TEL
03-3411-0111
sugiura.takahiro@navy.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Sugiura |
Organization
National hospital organization Tokyo Medical Center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902
TEL
03-3411-0111
Homepage URL
sugiura.takahiro@navy.plala.or.jp
Sponsor or person
Institute
National hospital organization Tokyo Medical Center
Institute
Department
Personal name
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
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
| 2015 | Year | 06 | 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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2016 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020942
