UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021537 |
|---|---|
| Receipt number | 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 16:21:59 |
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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
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
h-marumaru@jikei.ac.jp
Sponsor or person
Institute
The Jikei University Daisan Hospital Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024793
