UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013576 |
|---|---|
| Receipt number | R000015863 |
| Scientific Title | Time course of change in venous concentration of locally infiltrated morphine during total knee arthroplasty |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/06/16 12:07:27 |
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Basic information
Public title
Time course of change in venous concentration of locally infiltrated morphine during total knee arthroplasty
Acronym
Venous morphine concentration after knee infiltration
Scientific Title
Time course of change in venous concentration of locally infiltrated morphine during total knee arthroplasty
Scientific Title:Acronym
Venous morphine concentration after knee infiltration
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study drug disposition of morphine hydrochloride, which is infiltrated to tissue aroud the knee joint during total knee arthroplasty.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurement of venous concentration of morphine hydrochloride and its metabolites
Key secondary outcomes
measurement of postoperative pain scores and evalutation of incidence of opioid related side-effects.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
ASA physical status 1 or 2
receive total knee arthroplasty with general anesthesia
serum hemoglobin 10g/dl or more
operation performed by the specific operator
Key exclusion criteria
ASA physical status 3 or more
renal dysfunction (CKD stage3 or more)
cognitive dysfunction
known allergy to the drugs
diabetes mellitus
BMI35 or more
Rheumatic arthritis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoharu Funao |
Organization
Osaka City University, Graduate school of medicine.
Division name
Department of anesthesiology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka city
TEL
06-6443-2186
funaot@iris.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Fujimoto |
Organization
Osaka City University, Graduate school of medicine.
Division name
Department of anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abenoku, Osaka city
TEL
06-6645-2186
Homepage URL
yohei7@hera.eonet.ne.jp
Sponsor or person
Institute
Osaka City University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Osaka Medical Research Foundation for Intractable Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
nothing to inform
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2014 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015863
