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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017691 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Case to undergo mastectomy for malignant breast tumor with/without axillary lymphadenectomy | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Bolus: 0.375% levobupivacaine 20mL
Continuous: 0.25% levobupivacaine 4mL/hr |
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Interventions/Control_2 | bolus 0.75% levobupivacaine 10mL
Continuous: 0.25% levobupivacaine 4mL/hr |
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Interventions/Control_3 | Bolus: 0.25% levobupivacaine 20mL
Continuous: 0.25% levobupivacaine 4mL/hr |
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Interventions/Control_4 | Bolus: saline 20mL
Continuous: 0.25% levobupivacaine 4mL/hr |
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Sapporo Medical University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020504 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |