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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021537
Receipt No. R000024793
Scientific Title Safety and efficacy of catheter-over-needle and catheter-through-needle methods for continuous femoral nerve block: A prospective comparative study.
Date of disclosure of the study information 2016/03/24
Last modified on 2017/11/27

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Basic information
Public title Safety and efficacy of catheter-over-needle and catheter-through-needle methods for continuous femoral nerve block: A prospective comparative study.
Acronym Safety and efficacy of catheter-over-needle and catheter-through-needle methods for continuous femoral nerve block: A prospective comparative study.
Scientific Title Safety and efficacy of catheter-over-needle and catheter-through-needle methods for continuous femoral nerve block: A prospective comparative study.
Scientific Title:Acronym Safety and efficacy of catheter-over-needle and catheter-through-needle methods for continuous femoral nerve block: A prospective comparative study.
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove that catheter-over needle is less leakage from insertion site than catheter-through needle
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Leakage from the catheter insertion site after 50hours from starting continuos local anesthetic infusion.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In all cases, the catheter is inserted over-needle before surgery. after confirming the catheter position, 15ml of 0.25% ropivacaine is administered. Then, selective tibial nerve block is performed with single injection of 15ml 0.25%ropivacaine. After surgery, continuous infusion through the femoral block catheter is started with a drug solution containing 200ml of 0.25%levobupivacaine, 100ml of normal saline and 1.5ml of Indigo carmin(to identify leakage) at 6ml/hr.
Interventions/Control_2 In all cases, the catheter is inserted through-needle before surgery. after confirming the catheter position, 15ml of 0.25% ropivacaine is administered. Then, selective tibial nerve block is performed with single injection of 15ml 0.25%ropivacaine. After surgery, continuous infusion through the femoral block catheter is started with a drug solution containing 200ml of 0.25%levobupivacaine, 100ml of normal saline and 1.5ml of Indigo carmin(to identify leakage) at 6ml/hr.
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 Female
Key inclusion criteria elective total knee arthroplasty surgery

be comprehensible to the study

Key exclusion criteria Re-surgery case
Local anesthetic allergy
ASA PS>2
infection of insertion site
uncontrollable hypertension
severe diabetes mellitus(HbA1c>8.0%)
CKD Ccr<15ml/min
Systemic steroid administration (Predonin >20mg/day)
bleeding tendency
pregnant, lactating woman
be incomprehensible to the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyasu Hattammaru
Organization The Jikei University Daisan Hospital
Division name department of anesthesiology
Zip code
Address 4-11-1 Izumihon-cho, Komae City, Tokyo Japan
TEL 03-3480-1151
Email h-marumaru@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Hattammaru
Organization The Jikei University Daisan Hospital
Division name Department of anesthesiology
Zip code
Address 4-11-1 Izumihon-cho, Komae City, Tokyo Japan
TEL 03-3480-1151
Homepage URL
Email h-marumaru@jikei.ac.jp

Sponsor
Institute The Jikei University Daisan Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization The Jikei University Daisan Hospital
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 03 Month 24 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
2016 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 18 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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