UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019185 |
|---|---|
| Receipt number | R000022176 |
| Scientific Title | An Estimation of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/10/01 00:21:49 |
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Basic information
Public title
An Estimation of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block
Acronym
An Estimation of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block
Scientific Title
An Estimation of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block
Scientific Title:Acronym
An Estimation of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block
Region
| Japan |
Condition
Condition
patients undergoing surgery of the arm
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of the Minimum Effective Anesthetic Volume of 0.5% Levobupivacaine in Ultrasound- and Neurostimulation-guided Axillary Brachial Plexus Block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
minimum anesthetic effective volume of a 50
Key secondary outcomes
duration of analgesia, onset time and perioperative analgesic use or nonuse
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The starting dose was chosen as 5 ml per nerve of 0.5% levobupivacaine in the Axillary Brachial Plexus Block. Using a up-and-down method, the dose used for consective patients was determined by the outcome of the preceding block. In the case of block failure, we increase a dose by 0.5ml. In the case of block succeed, we reduce a dose by 0.5ml.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients undergoing surgery of the forearm, wrist, hand and finger
2) ASA risk 1 to 3
3) obtaining written informed consent
Key exclusion criteria
1) patients having allergic factors to local anesthetic
2) patients with the pregnant possibility
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Yamamoto |
Organization
Nihon University hospital
Division name
Department of Anesthsiology
Zip code
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
meyu12036@g.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Yamamoto |
Organization
Nihon University School of Medicine
Division name
Department of Anesthsiology
Zip code
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
meyu12036@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon 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
| 2015 | Year | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 14 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022176
