UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024739 |
|---|---|
| Receipt number | R000023431 |
| Scientific Title | The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy A Prospective, Randomized, Double-Blind Study |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2016/11/07 16:31:16 |
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Basic information
Public title
The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy
A Prospective, Randomized, Double-Blind Study
Acronym
The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy
A Prospective, Randomized, Double-Blind Study
Scientific Title
The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy
A Prospective, Randomized, Double-Blind Study
Scientific Title:Acronym
The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy
A Prospective, Randomized, Double-Blind Study
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of sciatic nerve block to femoral nerve block after high tibial osteotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The number of IV PCA boluses
Key secondary outcomes
The number of patients accomplished the trial, postoperative visual analog scale score (VAS score) at rest and at motion, the distribution of pain, the time of initial IV PCA bolus, postoperative nausea and vomiting (PONV), postoperative motor and neurological impairment and total amount of opioid used intraoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
continuous femoral nerve block
Interventions/Control_2
continuous sciatic nerve block
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
unilateral HTO
ASA-PS 1 or 2
Key exclusion criteria
DM patient with neuropathy
neuromuscular disease
vascular insufficiency of the lower limb
cognitive dysfunction
BMI over 35
renal impairment(eGFR under 60)
liver dysfunction
allergy to the drug used
stomach ulcer
pregnancy or lactation
QTc over 0.44
enable to take the block position
not appropriate for the study, dicision made by the doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hamada Takako |
Organization
Yokohama City University Hospital
Division name
Anesthesiology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa Pref.
TEL
045-787-2800
hamadatakako@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hamada Takako |
Organization
Yokohama City University Hospital
Division name
Anesthesiology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa Pref.
TEL
045-787-2800
Homepage URL
hamadatakako@hotmail.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
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
| 2016 | Year | 11 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 07 | 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
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2016 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023431
