UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025774 |
|---|---|
| Receipt number | R000029646 |
| Scientific Title | Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2018/04/02 04:51:29 |
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Basic information
Public title
Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Acronym
Investigation of PIB of LPB for THA
Scientific Title
Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Scientific Title:Acronym
Investigation of PIB of LPB for THA
Region
| Japan |
Condition
Condition
Total Hip Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of effective analgesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of pushed PCEA
The amount of fentanyl
Key secondary outcomes
Number of requested PCEA
Number of patients used additional analgesi
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The set flow rate was continuous 6mL of levobupivacaine 0.1% every hour and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
Interventions/Control_2
The set flow rate was intermittent bolus of 12mL of levobupivacaine 0.1% every 2 hours and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
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
Patients who schedule THA
Key exclusion criteria
secondary surgery
bilateral THA
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa University Hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL
0337848575
ueshimhi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa University Hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL
0337848575
Homepage URL
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Showa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Hospital
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
| 2017 | Year | 02 | Month | 01 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | 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
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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