UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041214 |
|---|---|
| Receipt number | R000047069 |
| Scientific Title | Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2020/07/27 13:03:06 |
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Basic information
Public title
Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Acronym
Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Scientific Title
Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Scientific Title:Acronym
Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the analgesic effect and motor function of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function and pain within 1 hour after surgery and analgesic duration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In surgery of the shoulder or upper arm, brachial plexus block is performed by the interscalene method after induction of anesthesia. At that time, 10 ml of 0.25% levobupivacaine is used as the drug.
Interventions/Control_2
In surgery of the shoulder or upper arm, brachial plexus block is performed by the interscalene method after induction of anesthesia. At that time, 10 ml of 0.125% levobupivacaine is used as the drug.
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
Patients scheduled for surgery on shoulder or upper arm
Key exclusion criteria
Patients who are taking antipsychotics, patients with mental illness, severe obesity (BMI 35 or higher), patients with chronic pain, patients who are taking opioids and analgesics, patients with dementia, and those who refuse to participate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Terashima |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
359-0513
Address
3-2 Namiki Tokorozawa Sitama
TEL
04-2995-1211
doc33043@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Terashima |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
359-0513
Address
3-2 Namiki Tokorozawa Sitama
TEL
04-2995-1211
Homepage URL
doc33043@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2 Namiki Tokorozawa Sitama
Tel
04-2995-1211
doc33043@ndmc.ac.jp
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
| 2020 | Year | 07 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047069
