UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017691 |
|---|---|
| Receipt number | R000020504 |
| Scientific Title | The efficacy and safety of peripheral nerve block: a randomized controlled study |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2016/10/10 09:30:09 |
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Basic information
Public title
The efficacy and safety of peripheral nerve block: a randomized controlled study
Acronym
The efficacy and safety of peripheral nerve block: a randomized controlled study
Scientific Title
The efficacy and safety of peripheral nerve block: a randomized controlled study
Scientific Title:Acronym
The efficacy and safety of peripheral nerve block: a randomized controlled study
Region
| Japan |
Condition
Condition
Case to undergo mastectomy for malignant breast tumor with/without axillary lymphadenectomy
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the arterial local anesthetic concentrations and efficacy of continuous paravertebral block lamina approach in patients after mastectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Arterial local anesthetic concentrations
Key secondary outcomes
Pain score
Elapsed time until first additional analgesia after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bolus: 0.375% levobupivacaine 20mL
Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_2
bolus 0.75% levobupivacaine 10mL
Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_3
Bolus: 0.25% levobupivacaine 20mL
Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_4
Bolus: saline 20mL
Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients (American Society of Anesthesiologists physical status I-III) scheduled for elective mastectomy with/without axillary lymphadenectomy for malignant breast tumor
Key exclusion criteria
Patients were excluded if they were younger than 18 years or older than 80 years of age, had a history of allergy to local anesthetics, had a history of neurological disorder affecting the corresponding limb, using opioid or analgesic regularly for chronic pain, or were pregnant.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(ext.3568)
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Murouchi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(ext.3568)
Homepage URL
murouchi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020504
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
