UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024739
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hamadatakako@hotmail.co.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.